Manager Institutional Review Board (FT), Office of Clinical Research Operations - Days

📁
Research/Science
📅
190001H9 Requisition #

Purpose:

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.
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. 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.

 

Responsibilities:

Management
1. Provides leadership and guidance to IRB Staff, IRB Members, the Research Community and in all aspects of day-to-day IRB operations – maintaining a culture of excellence, and superior customer service.
2. 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.
3. Assists in identifying and tracking key performance metrics for reporting staff performance management and integrates performance metrics into performance reviews.
4. Conducts regular staff meetings and addresses issues such as conflict and individual performance issues.
5. Reviews and analyzes overall performance metrics to ensure consistency among the IRB staff, IRB Committee(s), and the D-H HRPP Toolkit. Monitors the submission workflow in the electronic IRB system to ensure continued efficiency, including triaging tasks dependent upon volume and priority. Identifies process improvement opportunities to increase efficiency and effectiveness, while maintaining high standards of compliance and collaboration.

Regulatory/Operations
1. Assures that the IRB panel(s) and staff comply with the D-H HRPP Toolkit and performs duties as specified in the Toolkit.
2. Triages and assigns submissions to IRB Coordinators.
3. Oversees IRB reviewer assignments and attendance to ensure appropriate expertise is present/available.
4. Conducts quality assurance reviews for IRB meeting minutes and general post-review correspondence.
5. Assists with training of new IRB members and serves as a contact for member questions/concerns.
6. Demonstrates a clear, high-level knowledge, practice, and application of ICH/GCP guidelines, FDA regulations, HHS regulations, HIPPA Regulations and Confidentiality Policy, and IRB policies related to human subject protection and clinical research in general to ensure satisfactory compliance.
7. Serves as an IRB Committee alternate which includes the review of protocol submissions eligible for non-committee review and review of complex or time sensitive research protocols, requiring a higher level of understanding of the federal regulations and D-H policies.
8. 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.
9. Serves as a liaison for the Dartmouth College IRB office and external institutions seeking collaboration\single IRB review.
10. Oversees and maintains the D-H HRPP Toolkit and implements and communicates any updates and/or emerging regulations.
11. Oversees and maintains regulatory compliance documentation including D-H’s Federal Wide Assurance (FWA), IRB Registration with OHRP, FDA forms, Reliance Agreements, Commercial IRB contracts\agreements, and memorandums of understanding.
12. Maintains knowledge of existing affiliation agreements, contracts, and memorandum of understandings that affect local context considerations and reporting requirements.
13. Responds to researcher and IRB committee requests for clarification and guidance regarding ethical issues in biomedical and behavioral research involving human subjects.

 
Administrative\Education
1. 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.
2. 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.
3. 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.
4. Performs other duties as required or assigned.

Minimum Qualifications:

ü  Bachelor’s degree in a related field with a minimum of five (5) years of directly related experience; and a minimum of two (2) years of IRB management experience.

ü  Master’s degree preferred

ü  Certified IRB Professional (CIP) Certification preferred

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  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  CIP expected after one year in the job based on certification requirements.

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