Interview Guide for

Research Compliance Officer

This comprehensive interview guide for a Research Compliance Officer provides a structured approach to assess candidates' qualifications, experience, and suitability. By focusing on key compliance competencies, real-world experience handling research compliance issues, and ethical decision-making skills, this guide helps organizations identify candidates who can effectively navigate complex research regulations while supporting impactful research.

How to Use This Guide

This interview guide serves as a framework that you can customize to find the ideal Research Compliance Officer for your organization. To get the most value from this guide:

Modify questions and competencies to align with your organization's specific research activities, compliance requirements, and culture
Collaborate with stakeholders including research leaders, legal counsel, and executive team members to ensure all critical compliance areas are covered
Maintain consistency by asking the same core questions to all candidates, allowing for fair comparison
Use follow-up questions to delve deeper into candidates' experiences, uncovering their true knowledge and capabilities
Have each interviewer complete their scorecard independently before discussing candidates to prevent groupthink and bias

For additional guidance on making your interview process more effective, check out Yardstick's guide on structured interviewing and how to conduct effective job interviews.

Job Description

Research Compliance Officer

About [Company]

At [Company], we are committed to advancing knowledge and innovation through ethical and compliant research practices. As a leader in [Industry], we uphold the highest standards of integrity, safety, and responsibility in all our research activities.

The Role

The Research Compliance Officer plays a critical role in ensuring that [Company]'s research activities adhere to all applicable laws, regulations, and ethical standards. This position serves as a key advisor to researchers, leadership, and administrative staff on compliance matters, helping to create a culture of responsible conduct while enabling innovative research to flourish.

Key Responsibilities

Develop, implement, and oversee comprehensive research compliance programs covering areas such as IRB protocols, IACUC requirements, data security, and grant management
Monitor changes in federal, state, and institutional regulations that affect research activities and update policies accordingly
Conduct regular risk assessments and audits of research activities to identify potential compliance issues
Provide guidance and education to researchers and staff on compliance requirements and best practices
Investigate potential compliance violations and develop corrective action plans
Serve as a liaison with regulatory agencies and external oversight bodies
Create and deliver training programs on research compliance topics
Prepare compliance reports for leadership and regulatory bodies

What We're Looking For

Bachelor's degree required; advanced degree in a related field preferred (e.g., law, public health, science, etc.)
5+ years of experience in research compliance, preferably in a [Industry] setting
In-depth knowledge of federal regulations related to research (e.g., Common Rule, HIPAA, FDA regulations, NIH policies)
Strong analytical skills and attention to detail
Excellent communication and interpersonal abilities
Demonstrated ability to balance compliance requirements with research objectives
Problem-solving skills and sound ethical judgment
Collaborative approach and ability to build relationships across departments
Experience with compliance management systems preferred

Why Join [Company]

Be part of an organization that values integrity and excellence in research
Work with leading researchers and contribute to innovations that make a difference
Collaborative, inclusive culture that values diverse perspectives
Professional development opportunities to enhance your expertise in research compliance
Competitive compensation package including:
Salary range: [Pay Range]
Comprehensive health, dental, and vision benefits
Retirement plan with employer match
Generous paid time off and work-life balance initiatives

Hiring Process

We've designed our hiring process to be thorough yet efficient, ensuring we find the right fit while respecting your time.

Initial Screening Interview: A 30-minute phone conversation with our Talent Acquisition Specialist to discuss your background and interest in the role.
Compliance Experience Interview: A detailed discussion with the hiring manager about your experience in research compliance and how you've handled specific compliance situations.
Technical Assessment: A practical exercise that allows you to demonstrate your knowledge of research regulations and your approach to compliance challenges.
Behavioral Competency Interview: An in-depth conversation with key stakeholders to assess your approach to collaboration, problem-solving, and ethical decision-making.
Final Interview: A meeting with senior leadership to discuss your vision for the compliance function and how you would contribute to our organization's success.

Ideal Candidate Profile (Internal)

Role Overview

The Research Compliance Officer is responsible for developing, implementing, and overseeing comprehensive research compliance programs to ensure all research activities adhere to regulatory requirements and ethical standards. This role requires a blend of technical knowledge of research regulations, strategic thinking, and interpersonal skills to effectively guide researchers and leadership through complex compliance landscapes while supporting the advancement of important research initiatives.

Essential Behavioral Competencies

Ethical Judgment and Integrity - Demonstrates consistently sound ethical decision-making, upholds the highest standards of integrity in all situations, and serves as a model for ethical conduct throughout the organization. Maintains confidentiality and makes decisions that prioritize research integrity, participant safety, and organizational values.

Analytical Thinking - Systematically breaks down complex research compliance issues into component parts, identifies patterns and connections between seemingly unrelated problems, and evaluates multiple solutions using clear criteria. Applies regulatory frameworks to specific research contexts to determine appropriate compliance approaches.

Communication and Influence - Articulates complex compliance requirements clearly to diverse audiences, from researchers to executives. Tailors communication style and content appropriately. Persuasively builds support for compliance initiatives by connecting requirements to research objectives and organizational values.

Problem-Solving and Adaptability - Proactively identifies compliance issues, develops creative yet compliant solutions, and adjusts approaches as regulatory landscapes evolve. Demonstrates ability to navigate ambiguity and find workable solutions that balance compliance requirements with research needs.

Relationship Building - Builds and maintains productive working relationships with researchers, administrative staff, leadership, and external regulators. Creates an environment of trust where others feel comfortable seeking guidance on compliance matters. Demonstrates ability to navigate sensitive situations diplomatically.

Desired Outcomes

Establish and maintain a comprehensive research compliance program that effectively addresses all applicable regulations and meets or exceeds industry standards
Achieve and maintain strong compliance metrics with minimal disruption to research activities, including timely completion of required trainings and audits
Reduce compliance incidents by 20% within the first year through proactive education, monitoring, and process improvements
Successfully navigate external regulatory reviews and audits with minimal findings
Foster a culture of research integrity and compliance awareness through effective training and communication programs that reach 100% of research staff

Ideal Candidate Traits

The ideal Research Compliance Officer candidate demonstrates deep knowledge of research regulations and best practices, with particular expertise in [specific research areas relevant to company]. They have experience implementing and managing compliance programs in organizations of similar size and complexity to ours.

This person is both a strategic thinker who can design effective compliance systems and a hands-on problem solver who can address day-to-day compliance challenges. They possess excellent judgment and discretion, balancing strict regulatory adherence with practical solutions that support research objectives.

The successful candidate will be an effective communicator who can explain complex compliance requirements clearly to various audiences. They should have a collaborative, consultative approach that builds trust with researchers rather than creating an adversarial relationship. Experience with [specific compliance management systems or tools] is preferred but not required.

Most importantly, this person should be genuinely committed to research integrity and ethical conduct, viewing compliance not merely as rule enforcement but as a way to advance responsible research that benefits society.

Screening Interview

Directions for the Interviewer

This initial interview aims to assess whether the candidate has the fundamental qualifications and experience needed for the Research Compliance Officer role. Focus on understanding their background in research compliance, knowledge of key regulations, and their approach to balancing compliance with research objectives. This conversation will help determine if the candidate's experience aligns with our needs and if they should proceed to more in-depth interviews.

Be sure to take detailed notes on the candidate's responses, particularly regarding their specific experience with research compliance programs, types of research they've overseen, and how they've handled compliance challenges. While this is an initial screening, it's important to delve into specific examples rather than accepting generalized answers. Allow approximately 30-45 minutes for this interview, saving 5-10 minutes for candidate questions at the end.

Directions to Share with Candidate

Thank you for your interest in the Research Compliance Officer position. During this conversation, I'll ask about your background in research compliance, your experience with relevant regulations, and your approach to compliance challenges. This will help us understand if there's a good match between your experience and our needs. Please feel free to ask any questions you have about the role or our organization at the end of the interview.

Interview Questions

Please walk me through your professional background, highlighting your experience specifically related to research compliance.

Areas to Cover

Key roles and responsibilities in previous positions
Types of research they've supported (clinical, basic science, social science, etc.)
Size and scope of compliance programs they've managed
Career progression showing growth in compliance expertise
Educational background and relevant certifications

Possible Follow-up Questions

What compliance areas have you been responsible for (IRB, IACUC, export controls, etc.)?
How large were the research programs you supported in terms of funding or number of researchers?
What specific compliance management systems or tools have you used?

Describe your familiarity with key research regulations and guidelines. Which ones are you most experienced with?

Areas to Cover

Knowledge of Common Rule, HIPAA, FDA regulations, NIH policies
Understanding of state and local regulations that affect research
Experience with industry-specific compliance frameworks
Awareness of international research regulations if applicable
How they stay current with changing regulations

Possible Follow-up Questions

How have you implemented changes when regulations are updated?
Which regulatory bodies have you interacted with directly?
What resources do you use to stay updated on regulatory changes?

Tell me about a time when you had to address a significant research compliance issue. What was the situation, and how did you handle it?

Areas to Cover

Nature of the compliance issue and potential risks involved
Their approach to investigating the issue
How they developed and implemented corrective actions
Their communication with stakeholders during the process
Preventive measures they put in place afterward
Lessons learned from the experience

Possible Follow-up Questions

How did you balance addressing the compliance issue with maintaining research progress?
What was the outcome of your intervention?
How did you follow up to ensure similar issues didn't recur?

How do you approach balancing strict regulatory compliance with supporting innovative research?

Areas to Cover

Philosophy on compliance's role in research institutions
Specific strategies for being both a compliance enforcer and research enabler
Examples of finding creative but compliant solutions
How they build buy-in from researchers for compliance initiatives
Their approach to compliance education and training

Possible Follow-up Questions

Can you give an example of when you found a way to help researchers accomplish their goals while staying compliant?
How do you approach situations where researchers view compliance requirements as obstacles?
What techniques have you found most effective for getting researcher buy-in?

What experience do you have developing and delivering research compliance training programs?

Areas to Cover

Types of training programs they've developed
How they assess training effectiveness
Methods used to make compliance training engaging
Experience with different training formats (in-person, online, blended)
Approach to training different audiences (new researchers, seasoned PIs, etc.)

Possible Follow-up Questions

How do you measure the success of your training programs?
How have you handled training for specific populations with unique needs?
What techniques have you found most effective for making compliance training engaging?

What interests you about this Research Compliance Officer position at [Company]?

Areas to Cover

Knowledge of our organization's research areas
Alignment with our mission and values
Understanding of specific compliance challenges in our industry
Career goals and how this position fits their trajectory
What they find rewarding about compliance work

Possible Follow-up Questions

What aspects of our research program are you most excited to support?
How does this position align with your long-term career objectives?
What do you find most challenging and rewarding about research compliance work?

Interview Scorecard

Research Compliance Knowledge

0: Not Enough Information Gathered to Evaluate
1: Limited knowledge of research regulations; familiarity with only basic compliance concepts
2: Familiar with major regulations but lacks depth in certain areas important to our research
3: Solid understanding of all regulations relevant to our research areas; stays current with regulatory changes
4: Expert-level knowledge across multiple compliance domains; can speak to nuances of regulations and their practical application

Experience in Research Compliance

0: Not Enough Information Gathered to Evaluate
1: Limited direct experience in research compliance roles
2: Some experience but in narrower compliance areas or smaller research settings than our organization
3: Substantial experience that aligns well with the scope and complexity of our research program
4: Extensive experience managing comprehensive compliance programs in similar or more complex research environments

Problem-Solving Approach

0: Not Enough Information Gathered to Evaluate
1: Tends toward rigid application of rules without considering context or solutions
2: Can solve straightforward compliance issues but struggles with more complex situations
3: Demonstrates thoughtful approach to balancing compliance requirements with research needs
4: Shows exceptional ability to find creative, compliant solutions to complex challenges; strategic thinker

Communication Abilities

0: Not Enough Information Gathered to Evaluate
1: Communication lacks clarity or seems ineffective for researcher engagement
2: Communicates adequately but may struggle with certain audiences or complex topics
3: Articulates compliance concepts clearly; adapts communication style appropriately
4: Exceptional communicator; demonstrates ability to translate complex requirements into clear guidance and build support for compliance initiatives

Establish and maintain a comprehensive research compliance program

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal based on limited program management experience
2: Likely to Partially Achieve Goal but may struggle with comprehensive program oversight
3: Likely to Achieve Goal based on demonstrated experience with compliance program management
4: Likely to Exceed Goal with innovative approaches to compliance program development and management

Reduce compliance incidents through proactive education and monitoring

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal based on reactive rather than preventative approach
2: Likely to Partially Achieve Goal with standard training and monitoring approaches
3: Likely to Achieve Goal through systematic risk assessment and targeted interventions
4: Likely to Exceed Goal with innovative prevention strategies and metrics-driven improvements

Foster a culture of research integrity and compliance awareness

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal based on enforcement-focused rather than culture-building approach
2: Likely to Partially Achieve Goal but may struggle with researcher engagement
3: Likely to Achieve Goal through collaborative approach and effective communication
4: Likely to Exceed Goal by becoming a trusted advisor who influences organizational culture positively

Successfully navigate external regulatory reviews and audits

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal based on limited audit experience
2: Likely to Partially Achieve Goal but may struggle with more complex audit scenarios
3: Likely to Achieve Goal based on demonstrated audit preparation and management experience
4: Likely to Exceed Goal with strategic approach to preparation and relationship management with regulatory bodies

Recommendation to Proceed to Interview Loop

1: Strong No Hire - Significant gaps in experience or knowledge
2: No Hire - Some positive qualities but doesn't meet key requirements
3: Hire - Meets our requirements and would likely succeed in the role
4: Strong Hire - Exceptional candidate who exceeds requirements and would add significant value

Compliance Experience Interview

Directions for the Interviewer

This interview digs deeper into the candidate's specific experience with research compliance and regulatory frameworks. As the hiring manager, your goal is to thoroughly assess the candidate's knowledge of relevant regulations, their experience implementing compliance programs, and their ability to handle complex compliance situations. Focus on concrete examples from their past experience rather than hypothetical scenarios.

Allocate approximately 60 minutes for this interview, allowing adequate time for the candidate to provide detailed responses and examples. Listen carefully for evidence of not just their technical knowledge but also their judgment, problem-solving approach, and ability to balance compliance requirements with research objectives. Take detailed notes on specific examples they provide, particularly noting how they've handled challenging compliance situations. Save 10 minutes at the end for candidate questions.

Directions to Share with Candidate

During this interview, we'll explore your experience with research compliance in greater depth. I'll ask you to share specific examples of how you've handled various compliance situations and challenges. Please provide detailed descriptions of your role, the actions you took, and the outcomes of those actions. This will help us understand your approach to compliance management and your expertise with relevant regulations and processes.

Interview Questions

Walk me through your experience developing or improving research compliance programs. What were the key elements you focused on, and what results did you achieve? (Ethical Judgment and Integrity, Analytical Thinking)

Areas to Cover

Structure and scope of the compliance programs they've managed
Their methodology for assessing compliance needs and risks
Specific improvements or innovations they implemented
Metrics they used to measure program effectiveness
Challenges encountered and how they overcame them
Stakeholder engagement during program development

Possible Follow-up Questions

How did you determine which areas needed the most attention?
What resistance did you encounter, and how did you address it?
How did you secure resources and support for compliance initiatives?
How did you measure the success of your program improvements?

Describe your experience with specific types of research compliance (such as IRB, IACUC, export controls, conflict of interest, biosafety, etc.). Which areas are you most experienced with, and how have you applied this expertise? (Analytical Thinking)

Areas to Cover

Depth of knowledge in different compliance domains
Specific roles they've held related to each area
How they've applied their knowledge to actual research situations
Experience with relevant committees or boards
Any specialized training or certifications they hold
Awareness of common pitfalls or challenges in each area

Possible Follow-up Questions

What was your specific role in relation to the IRB/IACUC/other committees?
How have you handled situations involving multiple compliance areas?
What do you see as the most challenging aspects of each compliance area?
How do you approach keeping current with changes in these areas?

Tell me about a time when you had to conduct a compliance investigation or audit. What was the situation, your approach, and the outcome? (Analytical Thinking, Ethical Judgment and Integrity)

Areas to Cover

Nature and scope of the investigation/audit
Their methodology and investigative process
How they documented findings and developed recommendations
Their approach to sensitive or confidential aspects
How they communicated with stakeholders
Implementation of corrective actions
Lessons learned from the experience

Possible Follow-up Questions

How did you ensure a fair and thorough investigation?
How did you handle resistance or defensiveness from those being investigated?
What was challenging about this situation, and how did you overcome it?
How did you follow up to ensure corrective actions were effective?

Describe a situation where you had to manage a significant change in research regulations or policies. How did you approach implementing this change? (Problem-Solving and Adaptability, Communication and Influence)

Areas to Cover

The regulatory change and its impact on research activities
Their process for analyzing the change requirements
How they developed implementation strategies
Their approach to communicating changes to researchers and staff
Training or educational components they developed
How they monitored compliance with the new requirements
Challenges encountered and how they addressed them

Possible Follow-up Questions

How did you prioritize implementation steps?
How did you address researcher concerns about the changes?
What was most challenging about implementing this change?
How did you ensure consistent application of the new requirements?

Tell me about a time when researchers viewed compliance requirements as obstacles to their work. How did you address this situation while maintaining both compliance and good relationships? (Relationship Building, Communication and Influence)

Areas to Cover

Nature of the resistance encountered
Their approach to understanding researcher concerns
How they found balanced solutions
Their communication strategy and messaging
Steps taken to build trust and cooperation
Long-term strategies to improve compliance culture
The outcome of their intervention

Possible Follow-up Questions

How did you ensure you understood the researchers' perspective?
What specific strategies helped you gain their cooperation?
How did you follow up to ensure continued compliance?
What did you learn from this experience about effective compliance approaches?

Describe your experience working with regulatory agencies or managing external audits or inspections. What was your approach, and what outcomes did you achieve? (Communication and Influence, Problem-Solving and Adaptability)

Areas to Cover

Types of agencies and inspections they've worked with
Their role in preparing for and managing inspections
Their approach to communicating with regulators
How they addressed findings or citations
Their process for implementing corrective actions
Strategies to prevent similar issues in future inspections
Relationships built with regulatory personnel

Possible Follow-up Questions

What was your approach to preparing the organization for the inspection?
How did you manage anxiety or concerns from researchers or leadership?
How did you address any disagreements with inspectors' findings?
What systems did you put in place to prevent similar issues in the future?

Interview Scorecard

Depth of Compliance Program Experience

0: Not Enough Information Gathered to Evaluate
1: Limited experience in developing or managing comprehensive compliance programs
2: Has managed components of compliance programs but lacks experience with full program responsibility
3: Demonstrated experience developing and managing comprehensive compliance programs similar to our needs
4: Extensive experience building and improving sophisticated compliance programs, with demonstrable positive outcomes

Regulatory Knowledge and Application

0: Not Enough Information Gathered to Evaluate
1: Basic understanding of regulations but limited experience applying them to complex research situations
2: Good knowledge of major regulations but gaps in some areas relevant to our research
3: Comprehensive knowledge of regulations relevant to our research with proven ability to apply them appropriately
4: Expert-level knowledge across multiple regulatory frameworks with sophisticated understanding of application nuances

Investigation and Audit Experience

0: Not Enough Information Gathered to Evaluate
1: Limited experience conducting compliance investigations or managing audits
2: Some experience but with simpler cases or smaller scope than our needs
3: Solid experience with investigations and audits of similar complexity to our environment
4: Extensive experience managing complex investigations and audits with demonstrated skill in resolution and prevention

Change Management Abilities

0: Not Enough Information Gathered to Evaluate
1: Basic approach to implementing regulatory changes with minimal strategic planning
2: Can implement straightforward changes but may struggle with more complex regulatory shifts
3: Demonstrated ability to successfully implement significant regulatory changes with thoughtful planning
4: Sophisticated approach to change management with evidence of innovative implementation strategies and strong results

Relationship Management with Researchers

0: Not Enough Information Gathered to Evaluate
1: Enforcement-focused approach with limited evidence of collaborative relationships
2: Basic strategies for researcher engagement but may struggle with resistant stakeholders
3: Effective approaches to building researcher cooperation while maintaining compliance
4: Exceptional relationship-building skills with evidence of transforming compliance culture positively

Establish and maintain a comprehensive research compliance program

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal based on limited program development experience
2: Likely to Partially Achieve Goal but may struggle with more complex aspects of program management
3: Likely to Achieve Goal based on demonstrated compliance program expertise
4: Likely to Exceed Goal with innovative program design and management approaches

Reduce compliance incidents through proactive education and monitoring

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal due to reactive rather than preventative approach
2: Likely to Partially Achieve Goal but may lack sophisticated prevention strategies
3: Likely to Achieve Goal through systematic risk assessment and targeted interventions
4: Likely to Exceed Goal with evidence of successful incident reduction in previous roles

Foster a culture of research integrity and compliance awareness

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal due to enforcement-focused rather than culture-building approach
2: Likely to Partially Achieve Goal but may struggle with researcher engagement
3: Likely to Achieve Goal through demonstrated relationship-building skills
4: Likely to Exceed Goal with proven track record of positive culture transformation

Successfully navigate external regulatory reviews and audits

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal due to limited external audit experience
2: Likely to Partially Achieve Goal but may struggle with complex audit scenarios
3: Likely to Achieve Goal based on solid audit management experience
4: Likely to Exceed Goal with exceptional inspection preparation strategies and regulator relationship management

Recommendation

1: Strong No Hire - Significant gaps in compliance experience or knowledge
2: No Hire - Some positive qualities but doesn't meet our requirements in key areas
3: Hire - Strong compliance experience that aligns well with our needs
4: Strong Hire - Exceptional candidate with comprehensive compliance expertise who would elevate our program

Technical Assessment

Directions for the Interviewer

This assessment is designed to evaluate the candidate's practical knowledge of research compliance regulations and their ability to apply that knowledge to realistic scenarios. You'll present the candidate with compliance case studies that reflect challenges they might encounter in this role. The goal is to assess their analytical thinking, problem-solving approach, and ability to balance compliance requirements with research objectives.

Prepare by thoroughly reviewing the case studies and consider acceptable responses. During the assessment, observe not just the candidate's conclusions but their reasoning process and how they weigh different factors. Note their ability to identify relevant regulations, analyze risks, and develop practical solutions.

This assessment should take approximately 60-75 minutes, allowing 10-15 minutes for each case study plus time for introduction and candidate questions at the end. Provide the candidate with any reference materials they might need, such as excerpts from relevant regulations or institutional policies.

Directions to Share with Candidate

This assessment is designed to explore your approach to real-world research compliance situations. I'll present you with several case studies that reflect challenges you might encounter in this role. For each scenario, please:

Identify the key compliance issues involved
Explain which regulations or requirements apply
Outline how you would approach the situation
Describe what immediate actions you would take
Discuss any preventive measures you would recommend to avoid similar issues in the future

There are no perfect answers to these complex scenarios. We're interested in your thought process, analytical approach, and how you balance compliance requirements with practical research considerations.

Case Studies

Case Study 1: Protocol Deviation

You receive a report that a researcher has deviated from an IRB-approved protocol involving human subjects. Specifically, the research team collected additional data points not included in the approved protocol and extended the sampling timeframe without seeking amendment approval. The Principal Investigator claims these changes were minor and did not affect participant risk. How would you handle this situation?

Areas to Cover

Assessment of the deviation's severity and potential impact on subjects
Relevant regulations and requirements (Common Rule, institutional policies)
Investigation process to gather complete information
Communication with the researcher and IRB
Potential corrective actions and reporting requirements
Educational opportunities to prevent future deviations

Possible Follow-up Questions

How would you determine if this constitutes a serious or continuing non-compliance?
What factors would influence your decision about whether external reporting is required?
How would you balance addressing the compliance issue with maintaining a collaborative relationship with the researcher?
What preventive measures would you recommend implementing?

Case Study 2: Conflict of Interest Management

A prominent researcher at your organization has disclosed a significant financial interest in a company whose product they are studying in a clinical trial. The conflict of interest committee has recommended management strategies, but you've received concerns that the researcher isn't fully adhering to the management plan. How would you approach this situation?

Areas to Cover

Relevant regulations (PHS, FDA, institutional policies on conflicts of interest)
Investigation approach to verify compliance with management plan
Risk assessment regarding the integrity of the research
Options for addressing non-compliance with management plan
Considerations for protecting research participants and data integrity
Potential modifications to the management plan or oversight

Possible Follow-up Questions

How would you verify whether the management plan is being followed?
What stakeholders would you involve in addressing this issue?
What additional management strategies might you recommend?
How would you handle potential resistance from a high-profile researcher?

Case Study 3: Data Security and Privacy

You discover that research data containing identifiable health information has been stored on an unapproved cloud storage platform. The data is from an ongoing multi-site clinical trial. The researcher states they used this platform because it was easier to share data with collaborators at other institutions. What compliance issues does this raise, and how would you address them?

Areas to Cover

Relevant regulations (HIPAA, institutional data security policies)
Assessment of potential data breach implications
Immediate actions to secure the data
Investigation process to determine scope of exposure
Notification requirements and process
Development of compliant data sharing solution
Education and preventive measures

Possible Follow-up Questions

How would you determine if this constitutes a reportable breach?
What immediate actions would you take to mitigate risk?
What alternatives would you suggest for secure data sharing?
How would you approach preventing similar incidents across the organization?

Case Study 4: Export Control Compliance

A researcher plans to bring specialized research equipment to an international conference and collaborate with researchers from several countries, including some from restricted countries. The equipment isn't obviously export-controlled, but has potential dual-use applications. The researcher hasn't consulted with compliance before making these plans. How would you handle this situation?

Areas to Cover

Relevant regulations (EAR, ITAR, OFAC)
Process for determining if the equipment is export-controlled
Risk assessment regarding potential violations
Collaboration with export control specialists if available
Options for the researcher that ensure compliance
Communication approach with the researcher
Preventive measures for future international collaborations

Possible Follow-up Questions

How would you determine whether the equipment requires an export license?
What steps would you take if you determine an export license is required?
How would you handle this situation if the researcher has already made non-refundable travel arrangements?
What processes would you implement to catch these issues earlier?

Interview Scorecard

Regulatory Knowledge Application

0: Not Enough Information Gathered to Evaluate
1: Limited ability to identify relevant regulations and requirements
2: Identifies major regulatory issues but misses some important nuances or considerations
3: Accurately identifies applicable regulations and applies them appropriately to case studies
4: Demonstrates sophisticated understanding of regulatory frameworks with nuanced application to complex scenarios

Risk Assessment and Analysis

0: Not Enough Information Gathered to Evaluate
1: Superficial analysis of compliance risks with limited consideration of implications
2: Identifies obvious risks but may miss subtle or secondary concerns
3: Thoroughly analyzes risks with clear understanding of potential consequences
4: Exceptional analytical skills with comprehensive risk assessment across multiple dimensions

Problem-Solving Approach

0: Not Enough Information Gathered to Evaluate
1: Proposes rigid or by-the-book solutions that may not be practical
2: Develops workable solutions that address primary issues but may lack creativity
3: Creates balanced solutions that address compliance requirements while considering research needs
4: Develops innovative yet compliant approaches that effectively resolve complex issues

Investigation and Documentation Strategy

0: Not Enough Information Gathered to Evaluate
1: Limited or disorganized approach to fact-finding and documentation
2: Basic investigation approach that captures essential information
3: Thorough and methodical approach to gathering and documenting relevant information
4: Sophisticated investigation strategy that ensures comprehensive understanding of the situation

Communication and Stakeholder Management

0: Not Enough Information Gathered to Evaluate
1: Focuses primarily on enforcement with limited attention to relationship management
2: Balances enforcement with basic stakeholder considerations
3: Demonstrates thoughtful approach to communication that maintains relationships while ensuring compliance
4: Exceptional stakeholder management strategy that builds trust while effectively addressing compliance issues

Establish and maintain a comprehensive research compliance program

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal based on limited knowledge of program elements
2: Likely to Partially Achieve Goal but may struggle with program integration
3: Likely to Achieve Goal based on demonstrated understanding of effective compliance systems
4: Likely to Exceed Goal with innovative approaches to program design and management

Reduce compliance incidents through proactive education and monitoring

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal due to reactive rather than preventative approach
2: Likely to Partially Achieve Goal with basic preventive strategies
3: Likely to Achieve Goal through thoughtful preventive measures and monitoring systems
4: Likely to Exceed Goal with comprehensive prevention strategies that address root causes

Foster a culture of research integrity and compliance awareness

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal due to enforcement-focused approach
2: Likely to Partially Achieve Goal but may struggle with researcher engagement
3: Likely to Achieve Goal through balanced enforcement and education strategies
4: Likely to Exceed Goal with demonstrated ability to transform compliance perspective

Successfully navigate external regulatory reviews and audits

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal due to gaps in regulatory understanding
2: Likely to Partially Achieve Goal but may miss preparation opportunities
3: Likely to Achieve Goal through thorough preparation and management strategies
4: Likely to Exceed Goal with comprehensive audit readiness approaches

Recommendation

1: Strong No Hire - Significant gaps in technical knowledge or problem-solving ability
2: No Hire - Some technical knowledge but insufficient for our compliance needs
3: Hire - Strong technical capabilities that align with our compliance requirements
4: Strong Hire - Exceptional technical expertise with outstanding problem-solving skills

Behavioral Competency Interview

Directions for the Interviewer

This interview focuses on assessing the candidate's behavioral competencies that are critical for success as a Research Compliance Officer. Through structured behavioral questions, you'll evaluate how the candidate has demonstrated ethical judgment, analytical thinking, communication skills, problem-solving abilities, and relationship building in past situations.

Focus on getting specific examples from the candidate's experience rather than hypothetical responses or generalizations. Use the STAR method (Situation, Task, Action, Result) to guide the conversation and ensure you get complete information about each example. Listen carefully for evidence of the candidate's thought process, decision-making approach, and interpersonal skills.

Plan for a 60-minute interview, allowing approximately 10-12 minutes per competency area. Take detailed notes on the examples provided and how they demonstrate (or fail to demonstrate) the key competencies we're seeking. Reserve 5-10 minutes at the end for candidate questions.

Directions to Share with Candidate

In this interview, I'll ask you about specific situations from your past experience that relate to key competencies for the Research Compliance Officer role. For each question, please describe a specific example rather than speaking in generalizations or hypotheticals. Walk me through the situation, what you were tasked with doing, the actions you took, and the results you achieved. I'm interested in understanding your approach to various challenges and how you've applied your skills in real-world contexts.

Interview Questions

Describe a situation where you had to make a difficult ethical decision related to research compliance. What factors did you consider, and how did you reach your decision? (Ethical Judgment and Integrity)

Areas to Cover

Nature of the ethical dilemma and competing considerations
Their process for evaluating different perspectives and options
Key principles or values that guided their decision-making
How they handled pressure or disagreement from others
Their communication of the decision to stakeholders
The outcome and any lessons learned
How this experience has informed their approach to similar situations

Possible Follow-up Questions

How did you identify all the stakeholders who might be affected by your decision?
What resources or guidance did you consult when making this decision?
How did you communicate your decision to those who disagreed with it?
If you faced this situation again, would you approach it differently?

Tell me about a time when you had to analyze a complex compliance issue with multiple regulatory considerations. How did you approach the analysis? (Analytical Thinking)

Areas to Cover

The complexity of the issue and regulatory frameworks involved
Their methodology for breaking down the problem
How they gathered and assessed relevant information
Their process for identifying conflicts or gaps between requirements
How they weighed different factors in their analysis
Their conclusions and recommendations
How they documented their analysis for others

Possible Follow-up Questions

What was most challenging about analyzing this particular issue?
How did you handle ambiguities or gray areas in the regulations?
How did you validate your conclusions?
How did you communicate your analysis to non-compliance specialists?

Describe a situation where you needed to gain buy-in from researchers or leadership for a compliance initiative. What approach did you take? (Communication and Influence)

Areas to Cover

The compliance initiative and why it faced resistance
Their strategy for understanding stakeholder concerns
How they tailored their messaging to different audiences
Specific communication techniques they employed
How they addressed objections or concerns
The outcome of their influence efforts
Lessons learned about effective communication

Possible Follow-up Questions

How did you identify the key stakeholders whose support you needed?
What aspects of your approach were most effective in gaining buy-in?
How did you handle continued resistance from certain individuals?
How did you follow up to ensure continued support?

Tell me about a time when you had to develop a solution to a compliance challenge where there was no clear precedent or established procedure. How did you approach it? (Problem-Solving and Adaptability)

Areas to Cover

The nature of the novel compliance challenge
Their process for defining the problem and desired outcome
How they researched potential approaches or analogous situations
Their creativity in developing potential solutions
How they evaluated options and selected an approach
Implementation of their solution
Effectiveness of their solution and lessons learned

Possible Follow-up Questions

What resources did you consult when developing your approach?
How did you test or validate your solution before full implementation?
What obstacles did you encounter when implementing your solution?
How did you incorporate feedback to refine your approach?

Describe a situation where you had to build relationships with skeptical or resistant researchers to improve compliance. What specific strategies did you use? (Relationship Building)

Areas to Cover

The context and nature of the resistance they faced
Their approach to understanding researcher perspectives
Specific relationship-building strategies they employed
How they established credibility and trust
Their balance of firmness and flexibility
The evolution of the relationship over time
The impact on compliance outcomes

Possible Follow-up Questions

How did you initially approach these skeptical stakeholders?
What did you learn about their concerns or frustrations?
What was the turning point in building a more positive relationship?
How did this experience change your approach to researcher engagement?

Interview Scorecard

Ethical Judgment and Integrity

0: Not Enough Information Gathered to Evaluate
1: Shows concerning gaps in ethical reasoning or prioritizes expedience over proper process
2: Demonstrates basic ethical judgment but may struggle with more complex ethical dilemmas
3: Shows sound ethical reasoning with balanced consideration of multiple factors
4: Demonstrates exceptional ethical clarity and courage, even in difficult situations

Analytical Thinking

0: Not Enough Information Gathered to Evaluate
1: Analysis lacks thoroughness or systematic approach
2: Shows basic analytical skills but may miss important connections or implications
3: Demonstrates strong analytical ability with clear, logical reasoning
4: Exhibits sophisticated analysis that uncovers subtle relationships and implications

Communication and Influence

0: Not Enough Information Gathered to Evaluate
1: Communication approach is rigid or one-size-fits-all with limited persuasiveness
2: Communicates adequately but may struggle to adapt to different audiences or resistance
3: Demonstrates effective communication with thoughtful adaptation to audience needs
4: Shows exceptional communication skills with sophisticated influence strategies

Problem-Solving and Adaptability

0: Not Enough Information Gathered to Evaluate
1: Relies heavily on established procedures; limited creativity when facing novel situations
2: Can develop solutions to straightforward problems but may struggle with complexity
3: Demonstrates strong problem-solving with creative approaches to challenging situations
4: Shows exceptional ingenuity and adaptability with innovative yet practical solutions

Relationship Building

0: Not Enough Information Gathered to Evaluate
1: Focuses primarily on rule enforcement with limited attention to relationship dynamics
2: Makes basic efforts at relationship building but may struggle with more resistant stakeholders
3: Demonstrates effective relationship-building strategies that balance compliance needs with positive engagement
4: Shows exceptional ability to transform challenging relationships into productive partnerships

Establish and maintain a comprehensive research compliance program

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal based on limited strategic thinking or program development skills
2: Likely to Partially Achieve Goal with basic program components
3: Likely to Achieve Goal through demonstrated program development capabilities
4: Likely to Exceed Goal with exceptional strategic vision and implementation skills

Reduce compliance incidents through proactive education and monitoring

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal due to reactive approach to compliance issues
2: Likely to Partially Achieve Goal with standard prevention approaches
3: Likely to Achieve Goal through effective preventive strategies and monitoring
4: Likely to Exceed Goal with innovative approaches to prevention and early detection

Foster a culture of research integrity and compliance awareness

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal due to enforcement-focused rather than culture-building approach
2: Likely to Partially Achieve Goal but may struggle with cultural transformation
3: Likely to Achieve Goal through effective relationship building and communication
4: Likely to Exceed Goal with demonstrated ability to positively influence organizational culture

Successfully navigate external regulatory reviews and audits

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal due to gaps in preparation approach or regulatory understanding
2: Likely to Partially Achieve Goal but may struggle with more complex audit scenarios
3: Likely to Achieve Goal through thorough preparation and proactive management
4: Likely to Exceed Goal with sophisticated audit management strategies

Recommendation

1: Strong No Hire - Significant concerns in multiple competency areas
2: No Hire - Some positive qualities but doesn't meet requirements in key competency areas
3: Hire - Strong demonstration of required competencies
4: Strong Hire - Exceptional demonstration of all competencies with evidence of significant impact

Executive Leader Interview

Directions for the Interviewer

This interview provides an opportunity to assess the candidate's strategic thinking, leadership philosophy, and alignment with organizational values from a senior leadership perspective. Your role is to evaluate their vision for the compliance function, their ability to work effectively with institutional leadership, and their capacity to balance regulatory requirements with broader organizational objectives.

Focus on understanding their approach to managing the compliance function within a complex organization, their experience navigating organizational politics, and their ability to influence at senior levels. Assess not only their technical expertise but also their leadership potential and cultural fit with the executive team.

This interview should last approximately 45-60 minutes. Begin by establishing rapport, then progress through higher-level strategic and leadership questions. Allow time for the candidate to ask their own questions about the organization's vision, challenges, and expectations for this role. Reserve 10-15 minutes at the end for candidate questions.

Directions to Share with Candidate

In this conversation, I'd like to explore your vision for research compliance leadership and how you would approach working with our executive team to advance our research mission while ensuring regulatory compliance. We'll discuss your leadership philosophy, strategic thinking, and how you see compliance contributing to our overall organizational success. I'm interested in understanding both your experience and your perspective on effective compliance leadership in a complex research environment.

Interview Questions

What is your philosophy on how the compliance function should operate within a research organization? How would you balance regulatory requirements with supporting research innovation? (Ethical Judgment and Integrity, Relationship Building)

Areas to Cover

Their view of compliance's mission and purpose
How they balance enforcer vs. enabler roles
Their approach to establishing compliance as a value-add
Their perspective on appropriate independence vs. integration
How they would tailor their approach to our organization's culture
Examples from their experience that illustrate their philosophy

Possible Follow-up Questions

How has your compliance philosophy evolved during your career?
How would you measure success in a compliance leadership role?
How would you assess our current compliance culture, and what would you seek to change?
How do you handle situations where compliance requirements seem to directly conflict with research objectives?

Tell me about a time when you had to influence senior leadership regarding a significant compliance issue or initiative. What approach did you take, and what was the outcome? (Communication and Influence, Relationship Building)

Areas to Cover

The nature of the compliance issue and its organizational impact
Their strategy for engaging leadership
How they framed the issue and built their case
Their approach to addressing concerns or resistance
How they navigated organizational politics
The outcome of their influence efforts
Lessons learned about influencing upward

Possible Follow-up Questions

How did you prepare for this conversation with leadership?
What was most challenging about gaining leadership support?
How did you demonstrate the value of your proposal?
How did you follow up after gaining initial support?

How do you approach developing a compliance strategy that aligns with overall organizational objectives? Please provide a specific example from your experience. (Analytical Thinking, Problem-Solving and Adaptability)

Areas to Cover

Their methodology for understanding organizational priorities
How they assess compliance risks and requirements
Their process for developing strategic compliance initiatives
How they ensure alignment with broader objectives
Their approach to securing resources and support
Metrics they use to evaluate strategic success
Adaptability when organizational priorities shift

Possible Follow-up Questions

How do you prioritize compliance initiatives when resources are limited?
How do you communicate your compliance strategy to different stakeholders?
How do you handle emerging compliance risks that weren't part of your original strategy?
How do you ensure your compliance strategy remains relevant as regulations evolve?

What experience do you have transforming or elevating a compliance function? What approach did you take, and what were the results? (Problem-Solving and Adaptability, Communication and Influence)

Areas to Cover

The compliance function's initial state and key challenges
Their vision for transformation and key objectives
Their change management approach
Specific initiatives or improvements implemented
How they engaged stakeholders in the transformation
Obstacles encountered and how they overcame them
Measurable results and success indicators
Lessons learned from the experience

Possible Follow-up Questions

How did you determine which areas needed transformation?
How did you manage resistance to change?
What was most challenging about the transformation process?
What would you do differently if you were to undertake a similar transformation?

Research compliance involves multiple stakeholders with different priorities and perspectives. How do you approach building collaborative relationships while maintaining compliance standards? Please provide examples. (Relationship Building, Ethical Judgment and Integrity)

Areas to Cover

Their philosophy on stakeholder engagement
Specific relationship-building strategies they've employed
How they establish credibility and trust with diverse stakeholders
Their approach to difficult conversations about compliance
How they manage conflicts between stakeholder priorities
Their track record of successful collaborations
Examples of turning potentially adversarial relationships into partnerships

Possible Follow-up Questions

How do you tailor your approach to different stakeholder groups?
How do you maintain relationships while enforcing requirements?
How do you handle situations where stakeholders continue to resist compliance efforts?
What have you found most effective in building a collaborative compliance culture?

Interview Scorecard

Strategic Vision and Alignment

0: Not Enough Information Gathered to Evaluate
1: Limited strategic perspective; views compliance in isolation from organizational objectives
2: Basic understanding of alignment but may struggle to connect compliance to broader goals
3: Strong strategic vision with clear understanding of how compliance supports organizational mission
4: Exceptional strategic thinking with sophisticated understanding of compliance's role in organizational success

Leadership Philosophy and Approach

0: Not Enough Information Gathered to Evaluate
1: Narrowly focused on enforcement with limited leadership perspective
2: Demonstrates basic leadership capabilities but may lack sophistication in complex situations
3: Shows thoughtful leadership approach that balances compliance requirements with organizational needs
4: Demonstrates exceptional leadership philosophy with proven ability to elevate compliance function

Executive-Level Influence

0: Not Enough Information Gathered to Evaluate
1: Limited experience or effectiveness influencing at senior levels
2: Some success influencing leadership but may struggle with resistance or complexity
3: Demonstrated ability to effectively influence senior leadership on compliance matters
4: Exceptional track record of gaining executive support for significant compliance initiatives

Change Management Capabilities

0: Not Enough Information Gathered to Evaluate
1: Limited experience transforming compliance functions or programs
2: Has implemented changes but may lack comprehensive transformation experience
3: Strong change management approach with evidence of successful program transformation
4: Exceptional ability to elevate compliance functions with measurable positive outcomes

Stakeholder Management

0: Not Enough Information Gathered to Evaluate
1: Basic stakeholder engagement but may struggle with more complex relationship dynamics
2: Generally effective relationships but may have difficulty with certain stakeholder groups
3: Strong collaborative approach with demonstrated ability to work across diverse stakeholders
4: Exceptional relationship builder who transforms compliance perception among stakeholders

Establish and maintain a comprehensive research compliance program

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal based on limited strategic or program management capabilities
2: Likely to Partially Achieve Goal but may struggle with program integration
3: Likely to Achieve Goal through strong program development and management approach
4: Likely to Exceed Goal with visionary program leadership and integration

Reduce compliance incidents through proactive education and monitoring

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal due to reactive rather than preventative focus
2: Likely to Partially Achieve Goal with standard preventive approaches
3: Likely to Achieve Goal through strategic prevention initiatives
4: Likely to Exceed Goal with innovative prevention strategies and demonstrated results

Foster a culture of research integrity and compliance awareness

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal based on limited cultural influence capabilities
2: Likely to Partially Achieve Goal but may struggle with deeper cultural change
3: Likely to Achieve Goal through effective leadership and influence strategies
4: Likely to Exceed Goal with proven ability to transform organizational culture

Successfully navigate external regulatory reviews and audits

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal due to limited strategic preparation approach
2: Likely to Partially Achieve Goal but may miss opportunities for proactive management
3: Likely to Achieve Goal through comprehensive preparation and management
4: Likely to Exceed Goal with sophisticated audit strategy and regulator relationship management

Recommendation

1: Strong No Hire - Significant concerns about leadership capability or strategic alignment
2: No Hire - Some leadership qualities but insufficient for our organizational needs
3: Hire - Strong leadership capabilities that align with our organizational requirements
4: Strong Hire - Exceptional leader who would elevate our compliance function and add strategic value

Debrief Meeting

Directions for Conducting the Debrief Meeting

The Debrief Meeting is an open discussion for the hiring team members to share the information learned during the candidate interviews. Use the questions below to guide the discussion.Start the meeting by reviewing the requirements for the role and the key competencies and goals to succeed.

The meeting leader should strive to create an environment where it is okay to express opinions about the candidate that differ from the consensus or from leadership's opinions.
Scores and interview notes are important data points but should not be the sole factor in making the final decision.
Any hiring team member should feel free to change their recommendation as they learn new information and reflect on what they've learned.

Questions to Guide the Debrief Meeting

Question: Does anyone have any questions for the other interviewers about the candidate?

Guidance: The meeting facilitator should initially present themselves as neutral and try not to sway the conversation before others have a chance to speak up.

Question: Are there any additional comments about the Candidate?

Guidance: This is an opportunity for all the interviewers to share anything they learned that is important for the other interviewers to know.

Question: What is our assessment of the candidate's technical knowledge of research compliance regulations?

Guidance: Discuss specific examples from interviews that demonstrate the candidate's regulatory knowledge and ability to apply it to real situations.

Question: How effective would this candidate be at building relationships with researchers while maintaining compliance standards?

Guidance: Share observations about the candidate's communication style, influence strategies, and ability to balance enforcement with collaboration.

Question: Is there anything further we need to investigate before making a decision?

Guidance: Based on this discussion, you may decide to probe further on certain issues with the candidate or explore specific issues in the reference calls.

Question: Has anyone changed their hire/no-hire recommendation?

Guidance: This is an opportunity for the interviewers to change their recommendation from the new information they learned in this meeting.

Question: If the consensus is no hire, should the candidate be considered for other roles? If so, what roles?

Guidance: Discuss whether engaging with the candidate about a different role would be worthwhile.

Question: What are the next steps?

Guidance: If there is no consensus, follow the process for that situation (e.g., it is the hiring manager's decision). Further investigation may be needed before making the decision. If there is a consensus on hiring, reference checks could be the next step.

Reference Calls

Directions for Conducting Reference Calls

Reference checks are a critical component of our hiring process for the Research Compliance Officer position. They provide valuable third-party perspectives on the candidate's actual performance, knowledge, and working style. To make these reference calls most effective:

Ask the candidate to provide 2-3 professional references who can speak specifically to their compliance experience and leadership. Ideally, these should include at least one direct supervisor and one researcher or stakeholder they supported.
Request that the candidate contact these references in advance to notify them that you'll be reaching out, which typically results in more timely responses.
Approach these conversations as information-gathering discussions rather than merely verification checks. Ask open-ended questions and listen carefully for nuances in the responses.
Pay particular attention to how the reference describes the candidate's compliance approach, relationship-building skills, and impact on the research environment.
Be alert to any hesitations, qualifications, or patterns across multiple references that might signal concerns not evident during interviews.
Take detailed notes during each call to share with the hiring team during final deliberations.
Remember that these calls can be conducted by different members of the hiring team to gather diverse perspectives on the candidate.

Questions for Reference Calls

Could you describe your working relationship with [Candidate Name] and the context in which you worked together?

Guidance

Confirm the nature and duration of their working relationship
Understand the reference's perspective (supervisor, colleague, stakeholder, etc.)
Get details about the organization's research environment and compliance needs
Explore the candidate's specific responsibilities in that context

How would you describe [Candidate Name]'s expertise in research compliance regulations and requirements?

Guidance

Listen for specific examples of regulatory knowledge rather than general statements
Note which compliance areas the reference emphasizes or omits
Assess the depth of understanding versus breadth across multiple areas
Determine if the expertise aligns with your organization's compliance needs

Can you describe a specific compliance challenge that [Candidate Name] successfully addressed? What approach did they take, and what was the outcome?

Guidance

Note the complexity of the challenge and relevance to your environment
Listen for their problem-solving approach and whether it was collaborative
Assess the balance between ensuring compliance and supporting research
Determine the impact of their intervention on both compliance and stakeholders

How effective was [Candidate Name] at building relationships with researchers and other stakeholders while maintaining compliance standards?

Guidance

Listen for specific examples rather than general characterizations
Note any mention of difficult relationships and how they were handled
Determine if they were viewed primarily as an enforcer or as a partner
Assess their credibility and influence with different stakeholder groups

What would you say are [Candidate Name]'s greatest strengths in a compliance leadership role?

Guidance

Listen for alignment with your key competencies and needs
Note whether they emphasize technical skills, leadership abilities, or both
Ask for specific examples that demonstrate these strengths
Assess whether these strengths would translate well to your environment

Were there any areas where [Candidate Name] could have been more effective or needed development?

Guidance

Note how forthcoming the reference is about development areas
Listen for patterns that might align with observations from interviews
Ask how the candidate responded to feedback in these areas
Determine if these development needs would be significant in your role

On a scale of 1-10, how likely would you be to hire [Candidate Name] again for a similar role, and why?

Guidance

Note both the numerical rating and the explanation
Ask what would have made it a higher number if it's below 9-10
Listen for any hesitation or qualification in their response
Compare this answer with their earlier feedback for consistency

Reference Check Scorecard

Compliance Expertise

0: Not Enough Information Gathered to Evaluate
1: Limited knowledge or experience reported by reference
2: Basic compliance knowledge but lacking depth in areas important to our organization
3: Strong compliance expertise across relevant regulatory areas
4: Exceptional knowledge with demonstrated application to complex compliance situations

Problem-Solving Effectiveness

0: Not Enough Information Gathered to Evaluate
1: Primarily follows established protocols with limited creativity
2: Satisfactory problem-solving but may struggle with complex issues
3: Effective approach to compliance challenges with balanced solutions
4: Exceptional problem-solver who finds innovative yet compliant solutions

Relationship Management

0: Not Enough Information Gathered to Evaluate
1: Primarily enforcement-focused with limited stakeholder engagement
2: Basic relationship skills but may struggle with difficult stakeholders
3: Strong relationship builder who balances compliance with collaboration
4: Exceptional ability to transform compliance perception while maintaining standards

Leadership Impact

0: Not Enough Information Gathered to Evaluate
1: Limited impact on compliance culture or program effectiveness
2: Positive but modest impact on compliance program or stakeholder engagement
3: Significant positive influence on compliance effectiveness and culture
4: Transformative impact on compliance program, culture, and organizational approach

Establish and maintain a comprehensive research compliance program

0: Not Enough Information Gathered to Evaluate
1: Limited evidence of program development or management success
2: Basic program management capabilities with some positive results
3: Strong track record of establishing effective compliance programs
4: Exceptional history of building comprehensive, well-respected compliance programs

Reduce compliance incidents through proactive education and monitoring

0: Not Enough Information Gathered to Evaluate
1: Primarily reactive approach to compliance issues
2: Some preventative measures but limited systematic approach
3: Effective at implementing preventative strategies with positive results
4: Demonstrated significant reduction in compliance incidents through innovative prevention

Foster a culture of research integrity and compliance awareness

0: Not Enough Information Gathered to Evaluate
1: Limited success in influencing research culture
2: Some positive cultural impact but resistance remained
3: Effective at creating positive compliance culture with researcher buy-in
4: Transformative impact on organizational approach to research integrity

Successfully navigate external regulatory reviews and audits

0: Not Enough Information Gathered to Evaluate
1: Limited experience or success with regulatory reviews
2: Basic management of external audits with satisfactory outcomes
3: Effective preparation and management of regulatory reviews with positive results
4: Exceptional track record of successful regulatory interactions and audit outcomes

Frequently Asked Questions

How should I prepare for the Research Compliance Officer interview process?

Review the job description thoroughly and reflect on your experience with specific research regulations relevant to the role (e.g., IRB, IACUC, export controls, data privacy). Prepare detailed examples of how you've handled compliance challenges, built relationships with researchers, and developed compliance programs. Consider how you balance regulatory requirements with research objectives. Research [Company]'s research focus areas and consider how compliance supports their specific mission. You may find our article on how to conduct a job interview helpful for general interview preparation.

What types of case studies or scenarios might I encounter in the technical assessment?

The technical assessment will present realistic compliance scenarios that a Research Compliance Officer might face. These could include protocol deviations, conflicts of interest, data security breaches, export control considerations, or issues involving multiple regulatory frameworks. You'll be asked to identify relevant regulations, analyze risks, and develop appropriate responses. The goal is to assess your regulatory knowledge, analytical thinking, and problem-solving approach in situations similar to what you would encounter in the role.

How can I demonstrate my ability to balance compliance requirements with research objectives?

Share specific examples of how you've helped researchers navigate regulatory requirements while still achieving their research goals. Describe instances where you found creative but compliant solutions to complex challenges. Explain your philosophy on compliance as an enabler rather than just an enforcer. Discuss how you've built positive relationships with researchers to foster a culture of compliance. Emphasize your commitment to research integrity while showing that you understand the importance of advancing knowledge through research.

What if I have more experience in some compliance areas than others?

Be honest about your areas of strength and where you have less experience. Emphasize your transferable skills and your ability to learn new regulatory frameworks quickly. Describe how you've successfully applied compliance principles across different contexts. Highlight your approach to assessing and addressing compliance risks in unfamiliar areas. Most organizations don't expect expertise in every compliance domain, but they do want someone who can effectively identify gaps and develop strategies to address them.

How should I approach discussing difficult compliance situations I've handled in the past?

When discussing challenging compliance situations, clearly explain the context, the specific compliance issues involved, and the competing factors at play. Describe your thought process, the steps you took to gather information, and how you reached your decisions. Be transparent about any difficulties you encountered and what you learned from the experience. Organizations value candidates who can demonstrate sound judgment, ethical decision-making, and the ability to learn from both successes and setbacks.

What if my compliance experience comes from a different industry or research setting?

Focus on the transferable aspects of compliance management - risk assessment, policy development, education, monitoring, and relationship building. Highlight your ability to learn new regulatory frameworks and apply compliance principles in different contexts. Discuss how you've successfully adapted to new compliance environments in the past. Ask thoughtful questions about the specific compliance needs of the organization to show your interest in understanding their unique challenges. Many compliance skills are transferable across research settings, even if the specific regulations differ.