Director of Human Research Protection Program

📁
Research/Science
📅
190001H8 Requisition #

Purpose:

Provides leadership for the protection of human research participants for Dartmouth-Hitchcock (D-H). Responsible for institutional compliance with international, federal, and state rules, regulations, guidance, and laws regarding the conduct of research involving human research participants and for accreditation of the Human Research Protection Program (HRPP) by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Fosters a culture of responsible conduct of human participant research and engages with the Office of General Counsel, other compliance areas as well as researchers and institutional human research support structures to achieve this end.

 

Responsibilities:

Regulatory/Policy
1. Leads the development of institutional policies and procedures for the protection of human research participants.
2. Reviews proposed changes to federal and state regulations and laws affecting the participation of human research participants and plays a leadership role in responding.
3. Oversees updates to the HRPP Toolkit including development/changes of forms, applications and instructions and disseminates information about changes to the D-H community to ensure uninterrupted compliance.
4. Negotiates and maintains the Federal Wide Assurance (FWA) and cooperative agreements necessary to ensure compliance with federal requirements.
5. Oversees HRPP program to maintain AAHRPP accreditation and leads coordination of all accreditation activities including site visits and responding to issues raised by AAHRPP.
6. Ensures that projects of a special nature, including research conducted outside of the United States, are approved and documented in accordance with federal and local regulations.
7. Serves as liaison with federal officials and national organizations.
8. Serves as internal within D-H including but not limited to, the Office of General Counsel, the Office of Sponsored Projects (OSP) and the Clinical Trials Office (CTO).
Management
9. Provides leadership and guidance to the Institutional Official, IRB Chairs, and the research community to ensure compliance with federal regulations with the aim of the protection of human subjects.
10. During the period of Institutional Review Board (IRB), manages recruitment and serves as the direct supervisor for IRB staff while providing guidance and leadership to IRB members, the Research Community, and in all aspects of day-to-day IRB operations – maintaining a culture of excellence and superior customer service.
11. Works with leadership to develop and manage the HRPP budget.
12. Develops and maintains an effective performance evaluation program for staff and committee members.
13. Oversees HRPP record keeping to support the maintenance of federal assurances for local review of human research.
14. Defines and oversees process improvement initiatives including defining metrics, preparing and presenting reports.
15. Defines and oversees communication enhancements and quality assurance/quality improvement plans.
16. Oversees the HRPP systems and tools that support all application, review and communication processes associated with human research protection.
17. Serves as an IRB Committee alternate to assist as needed with the review of complex or time sensitive research protocols, requiring a higher level of understanding of the federal regulations and D-H policies.
18. Serves as the direct supervisor for IRB staff, including tracking performance, conducting annual performance evaluations, and providing guidance in operations or human research regulations, as necessary.


Administrative\Education
19. Advises the Institutional Official regarding committee membership as it relates to federal requirements and D-H policy.
20. Identifies the need for replacing members when resignations occur or when terms expire and recruits and recommends non-affiliated members and evaluates recommendations for scientist and non-scientist members.
21. Works closely with D-H leaders in the identification and selection of members.
22. Represents the D-H HRPP. Educates various audiences on the purpose and relevance of IRB policies and procedures.
23. Provides leadership in establishing and prioritizing work plans and long-range goals for the enhancement of the HRPP.
24. Continually assesses the current state of research and pursues a strategic plan that supports future growth as it pertains to human subject research protection, including resource and FTE needs, programmatic needs and necessary compliance initiatives.
25. Identifies educational needs and establishes on-going education and communication of regulatory changes and alterations to the human subject research landscape; provides presentations to the research and works in concert with others on these initiatives for the education of the D-H research community.
26. Performs other duties as required or assigned.

Minimum Qualifications:

ü  Bachelor’s degree in a related field with a minimum of seven (7) years of directly related experience; and a minimum of five (5) years of IRB management experience.

ü  Master’s degree preferred

ü  Expertise in regulations pertaining to the protection of human subjects, including HHS, FDA, and HIPAA.

ü  Knowledge of Microsoft Office Programs: Word, Excel, PowerPoint, Outlook; Internet Functions.

ü  Prior experience in a hospital research setting, university research setting, and\or clinical research operation.

ü  Experience in staff supervision and management.

ü  Ability to initiate, plan, organize, and bring projects to conclusion without direct supervision.

ü  Detail-oriented with the ability to multi-task and prioritize workload.

ü  Excellent communication (written and oral), organization, and customer service skills.

 

Required Licensure/Certification Skills:

ü  Certified IRB Professional (CIP) required

My Profile

Create and manage profiles for future opportunities.

Go to Profile

My Submissions

Track your opportunities.

My Submissions

Similar Listings

Lebanon, NH, USA

📁 Research/Science

Lebanon, NH, USA

📁 Research/Science