The Director of Human Research Protection Program provides leadership for the protection of human research participants for Dartmouth-Hitchcock (D-H) and is 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). The Director 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.
Leads the development of institutional policies and procedures for the protection of human research participants.
Reviews proposed changes to federal and state regulations and laws affecting the participation of human research participants and plays a leadership role in responding.
Oversees updates to the HRPP Toolkit to ensure uninterrupted compliance.
Negotiates and maintains the Federal Wide Assurance (FWA) and cooperative agreements necessary to ensure compliance with federal requirements.
Oversees HRPP program to maintain AAHRPP accreditation and leads coordination of all accreditation activities including site visits and responding to issues raised by AAHRPP.
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.
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.
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.
Advises the Institutional Official regarding committee membership as it relates to federal requirements and D-H policy.
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.
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.
Performs other duties as required or assigned.
Bachelor’s degree in a related field with a minimum of 7 years of directly related experience; and a minimum of 5years of IRB management experience. Master’s degree preferred.
Expertise in regulations pertaining to the protection of human subjects, including HHS, FDA, and HIPAA.
Prior experience in a hospital research setting, university research setting, and\or clinical research operation.
Required Licensure/Certification Skills:
Certified IRB Professional (CIP) required.
The Dartmouth-Hitchcock health system stretches over New Hampshire and Vermont and offers the quintessential New England experience. Anchored by the academic Dartmouth-Hitchcock Medical Center in Lebanon, NH, the system includes the NCI-designated Norris Cotton Cancer Center, the Children’s Hospital at Dartmouth-Hitchcock; 4 affiliated hospitals and 30 Dartmouth- Hitchcock ambulatory clinics across the region. With no income or sales tax, this beautiful area combines history, industry and business and has been ranked consistently as one of the best places in the US to live and work. With destinations like Boston, New York, the seacoast and ski country within driving distance, the opportunities - both career and personal - truly make New Hampshire the ideal place to work and play.
Applicants are encouraged to apply online, Req #190001H8:
Dartmouth-Hitchcock is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, veteran status, gender identity or expression, or any other characteristic protected by law.
Internal Number: 190001H8
How can the lifestyle in New Hampshire and Vermont compliment your career? You can have amazing 4-season living with a career at one of the top health systems in the country. The Dartmouth-Hitchcock health system stretches over New Hampshire and Vermont and offers the quintessential New England experience. With no income or sales tax, this beautiful area combines history, industry and business and has been ranked consistently as one of the best places in the US to live and work. Anchored by the academic Dartmouth-Hitchcock Medical Center in Lebanon, NH, the system includes the NCI-designated Norris Cotton Cancer Center, the Children's Hospital at Dartmouth-Hitchcock; 4 affiliated hospitals and 30 Dartmouth-Hitchcock ambulatory clinics across the region. We are close to the urban centers of Boston, New York and Montreal, but also offer proximity to the seacoast and multiple top-tier ski mountains within a short driving distance. Throughout New Hampshire, the opportunities – both career and personal – truly make our area the ideal place to work and play.Dartmouth-Hitchcock is an equal opportunity employer and all qualified applicants will receive consideration for employment without ...regard to race, color, religion, gender, national origin, disability status, veteran status, or any other characteristic protected by law.