Senior Institutional Review Board Reliance Coordinator (FT), Office of Clinical Research Operations - Days

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Research/Science
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190001HA Requisition #

Purpose:

Provides regulatory expertise, guidance and administrative support to the Dartmouth-Hitchcock (D-H) Institutional Review Board (IRB). Responsible for managing the relationships between D-H and external IRBs, as well as external sites for multi-site research projects for which D-H is the IRB of record. Manages the workflow for execution of IRB authorization agreements (IAAs) and collecting information to populate Institution Profiles in the IRB system.

 

Responsibilities:

1. Manages the review and execution of IAAs. This duty includes:
a. Performs the initial review of all IAAs.
b. Evaluates all documents associated with IAAs (SOPs, templates, and forms) when D-H is contemplating reliance.
c. Engages Human Research Protection Program (HRPP) leadership and the Office of General Counsel, as appropriate to assist with the review of reliance agreements and associate documents.
d. Maintains records of existing IAAs, contracts, and memorandum of understandings that affect local context considerations and reporting requirements.
e. Reviews (no less than annually) the status of IAAs and following up, as needed to update or recommend termination.
f. Identifies and manages cases where concerns may arise related to overlap with other IRB review arrangements.
2. Serves as liaison between D-H IRB, researchers and external organizations/IRBs regarding IRB reliance issues.
3. Complies with the D-H HRPP Toolkit which includes applicable local and federal regulations, rules, guidelines and ethical principles and performs duties as specified in the D-H HRPP Toolkit.
4. Works with HRPP leadership to update the D-H HRPP Toolkit as needed related to IRB reliance.
5. Provides consultation to researchers inquiring about the IAA agreement process.
6. For studies in which D-H is the relying IRB:
a. Reviews and manages requests from D-H investigators to rely on an external IRB, determines eligibility for reliance and communicates reliance determinations to the investigator.
b. Ensures that all D-H institutional requirements for human subjects research, such as ancillary reviews, are completed.
c. Serves as liaison with reviewing IRB for IRB and study related matters including questions related to institutional requirements and local context.
7. For studies in which D-H is the IRB of record for multi-site projects:
a. Reviews and manages requests from external organizations/investigators to rely on the D-H IRB.
b. Determines eligibility for reliance and communicates reliance determinations to the D-H investigator and site investigator.
c. Serves as the liaison with the relying IRBs for IRB and study related matters.
8. Acts as a liaison to facilitate reliance relationships through national reliance initiatives. Works with HRPP leadership to identify and resolve problems and improve efficiency and effectiveness of IRB reliance process.
9. Assists with training and education for investigators, study teams, IRB members and others on the IRB reliance process.
10. Performs other duties as required or assigned.

Minimum Qualifications:

ü  Bachelor’s degree in a relate field or the equivalent in education and experience required, with a minimum of three (3) years of directly related experience preferred.

ü  Certified IRB Professional (CIP) Certification (preferred)

ü  Other combination of education and work experience that provides required knowledge, skills, and abilities deemed necessary for this position allowed.

ü  Prior IRB experience required

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  Strong knowledge of protocol processes and approval mechanisms included in ongoing human subject research oversight.

ü  Strong communication (written and oral), interpersonal, and customer service skills needed to work closely and effectively with researchers, committee members and administrative personnel.

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

 

Required Licensure/Certification Skills:

ü  Certified IRB Professional (CIP) expected after one year in the job based on certification requirements.

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