Job: Director, Human Research Protection Program - Research Regulatory Affairs

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Job Description

Research Regulatory Affairs

Full Time (40 hours per week)

Day Shift

8:00am - 5:00pm

Job Details:

National Jewish Health (NJH) is currently seeking a Human Research Protection Program (HRPP) Director to join our dynamic Research Regulatory Affairs team. The candidate selected for this role will be a team player who is detail oriented and motivated to support NJH's world-class research community. This position will impact the institution by expanding our HRPP and developing a robust quality improvement and education component of our program. The ideal candidate will display a high level of initiative and independent judgment.

Essential Duties

1. Provide direction and integrative coordination in the planning, development and implementation of the HRPP.

2. Establish and implement short-and long-range goals, objectives, policies and operating procedures; monitor and evaluate operational effectiveness and affect changes required for improvement.

3. Supervises and develops an effective staff: providing effective communication, leadership, guidance and resources. Partners with Director to determine staff qualifications and competency: recruits, interviews, selects, hires, trains, orients, mentors, evaluates, coaches, counsels, disciplines, and rewards.

4. Serve as principal point of collaboration, leadership & expertise to both internal constituencies (e.g., Research Pharmacy, Institutional Biosafety Committee, Radiation Safety, Privacy and Security Offices, Grants Office, etc.) and external constituencies (funding and federal oversight agencies) on professional and operational matters pertaining to the HRPP.

5. Maintain a current knowledge of Federal, State, & Organizational laws, regulations, policies and guidelines governing human subject research; participate in and provide education and training. Interpret and apply federal, state and local regulations, policies and procedures related to research involving human participants.

6. Develop and maintain positive relationships with collaborating organizations. Act as liaison with federal and state agencies on human research issues.

7. Work closely with Institutional leadership to ensure compliance with the ethical and regulatory requirements for human subjects research.

8. Design, develop, implement, evaluate, & modify technical and administrative IRB review processes and internal research auditing policies, protocols, systems, and procedures.

9. Work with appropriate internal resources to analyze data and prepare and present IRB audit reports and summaries, and provide feedback to the Institutional Official/Designee, researchers and the IRB as appropriate.

10. Oversee the identification of the educational needs of researchers, based on audit data and other information; oversee the development & delivery of targeted training programs and materials based on IRB review and audit results, as well as on changes to legislative, statutory, and/or Organizational requirements.

11. Provide advice, guidance, and problem resolution to research investigators and support personnel in the application of relevant Federal, State, and Organizational laws, regulations, and guidelines.

12. Assist with specific inquiries related to scientific misconduct &/or IRB-related non-compliance issues, as requested.

Other Duties

1. Applies for HRPP accreditation as authorized.


1. Building Strategic Relationships: Identifying opportunities and taking action to build strategic relationships between one's area and other areas, teams, departments, units, or organizations to help achieve business goals.

2. Champion of Change: Facilitating the implementation and acceptance of change within the workplace. Cooperates with others to accomplish common goals; works with employees within and across his/her department to achieve shared goals; treats others with dignity and respect and maintains a friendly demeanor; values the contributions of others.

3. Coaching and Teaching Others: Providing timely guidance and feedback to help others strengthen specific knowledge/skill areas needed to accomplish a task or solve a problem.

4. Collaboration/Teamwork: Cooperates with others to accomplish common goals; works with employees within and across his/her department to achieve shared goals; treats others with dignity and respect and maintains a friendly demeanor; values the contributions of others.

5. Creativity and Innovation: Applies creative problem-solving skills to develop solutions to problems; recognizes and demonstrates the value in taking "smart" risks and learning from mistakes; develops multiple alternatives and understands the feasibility of each; effectively shares and implements his/her ideas. Generates innovative solutions in work situations; tries different and novel ways to deal with work problems and opportunities.

6. Decision Making: Identifying and understanding issues, problems, and opportunities; comparing data from different sources to draw conclusions; using effective approaches for choosing a course of action or developing appropriate solutions; taking action that is consistent with available facts, constraints, and probable consequences.

7. Impact and Influence: Using appropriate interpersonal styles and techniques to gain acceptance of ideas or plans; modifying one's own behavior to accommodate tasks, situations, and individuals involved. Taking advantage of opportunities to make a difference and have an impact. When used well, the intended outcome of this competency is the creation of goodwill, trust, and respect while motivating people to want to follow you even when they don't have to.

8. Informing and Communicating: Clearly conveying information and ideas through a variety of media to individuals or groups in a manner that engages the audience and helps them understand and retain the message.

9. Managing Conflict: Dealing effectively with others in an antagonistic situation; using appropriate interpersonal styles and methods to reduce tension or conflict between two or more people. Addresses conflicts by focusing on the issues at hand to develop effective solutions when disputes or disagreements occur; helps others resolve conflicts by providing impartial mediation when needed.

10. Talent Management for Leaders: Clearly establishes and communicates expectations and accountabilities; monitors and evaluates performance; provides effective feedback and coaching; identifies development needs and helps employees address them to achieve optimal performance.

Supervisory or Managerial Responsibility

1 - 5 employees



Core Values

1. Be available to work as scheduled and report to work on time.

2. Be willing to accept supervision and work well with others.

3. Be well groomed, appropriately for your role and wear ID Badge visibly.

4. Be in compliance with all departmental and institutional policies, the Employee Handbook, Code of Conduct and completes NetLearning by due date annually.

5. Fosters an inclusive workplace where diversity and individual differences are valued and leveraged to achieve the vision and mission of the institution.

6. Adheres to safe working practices and at all times follows all institutional and departmental safety policies and procedures.

7. Wears appropriate PPE as outlined by the infection control policies and procedures.

8. Demonstrates compliance with all state, federal and all other regulatory agency requirements.

Minimum Qualifications


Bachelor's degree in related field required. Master's degree preferred.

Work Experience

Seven (7) years of experience in Human Research Protection Program. Five (5) years of experience leading the work of others required. Knowledge of HIPAA regulations and state privacy laws. Working knowledge of good clinical/research practices and standards. Prior Biomedical or Social and Behavior research experience preferred.

Special Training, Certification or Licensure

Certified IRB Professional (CIP) or other appropriate certification as a research professional strongly preferred.



National Jewish Health
Human Resources
1400 Jackson St
Denver, CO 80206
Job Line: 1.800.686.9512


© 2017 National Jewish Health, Policies & Guidelines

National Jewish Health is a non-profit, non-sectarian institution and is a longstanding cornerstone in the Denver healthcare community. National Jewish Health seeks to attract the best-qualified candidates who support the mission, vision and values of the Institution and those who respect and promote excellence through diversity. We are committed to providing equal employment opportunities (EEO) to all employees and applicants without regard to race, color, creed, religion, sex, age, national origin, citizenship, sexual orientation, gender identity and expression, physical or mental disability, marital, familial or parental status, genetic information, military status, veteran status or any other legally protected classification. We are a tobacco and fragrance free environment.