The Institutional Review Board Manager provides leadership support for the Dartmouth-Hitchcock (D-H) Human Research Protection Program (HRPP) to ensure compliance with applicable laws, regulations, and policies, including standards of excellence necessary for achieving accreditation status. The Manager has the responsibility of overseeing the human subject research protocol submission and review process and determining whether components of proposed research are in compliance with federal, state and local regulations, and the D-H HRPP Toolkit. The Manager supervises IRB staff; serves as a liaison between the research community, the IRB staff, and the IRB reviewer; educates parties on relevant and emerging regulations and identifies\investigates any instances of possible non-compliance\ research misconduct.
Provides leadership and guidance to IRB Staff, 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.
Reviews and analyzes overall performance metrics to ensure consistency among the IRB staff, IRB Committee(s), and the D-H HRPP Toolkit.
Assures that the IRB panel(s) and staff comply with the D-H HRPP Toolkit and performs duties as specified in the Toolkit.
Assists with training of new IRB members and serves as a contact for member questions/concerns.
Serves as a liaison between the research community, the IRB staff and the IRB reviewers and educates parties on relevant and emerging regulations and any related risk management issues.
Maintains knowledge of existing affiliation agreements, contracts, and memorandum of understandings that affect local context considerations and reporting requirements.
Continually assesses the current state of research and pursues a strategic plan that supports future growth as it pertains to human subject research protection.
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 community and works in concert with others on these initiatives for the education of the D-H research community.
Ensures the compliance and accuracy of the D-H IRB intranet website, which include items such as: the HRPP Toolkit including IRB policies and procedures, reporting requirements, and SOPs.
Performs other duties as required or assigned.
Bachelor’s degree in a related field with a minimum of 5 years of directly related experience; and a minimum of 2 years of IRB management experience. Master’s degree preferred.
Certified IRB Professional (CIP) Certification preferred and prior IRB experience required.
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. Experience in staff supervision and management.
Required Licensure/Certification Skills:
CIP expected after one year in the job based on certification requirements.
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 #190001H9:
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: 190001H9
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.