Provides regulatory expertise, guidance and administrative support to the Dartmouth-Hitchcock (D-H) Institutional Review Board(s) (IRB).

Responsible for processing submissions according to the policies and procedures outlined in the D-H Human Research Protection Program (HRPP) Toolkit and serves as a regulatory resource to support IRB reviews. Has the primary responsibility of moving submissions through the office workflow in a timely manner, ensuring that submissions are review ready prior to routing for review, conducting certain non-committee reviews, and generating correspondence after the review process is complete along with coordinating the activities of IRB panels.

1. Complies with the D-H HRPP Toolkit which includes applicable local and federal regulations, rules, guidelines and ethical principles and perform duties as specified in the D-H HRPP Toolkit.
2. Processes submissions to the IRB Office as assigned, including New Studies, Modifications, Continuing Review, and Reports of New Information. Conducts pre-review to ensure that submissions are review ready, routes submissions appropriately for either non-committee or committee review and communicates review results to investigators and others as needed.
3. Escalates matters of concern to the HRPP Director or IRB Manager as appropriate.
4. Conducts non-committee review for certain submissions as determined by the HRPP Director or the IRB Manager.
5. Prepares for, coordinates and facilitates IRB Committee meetings, which includes, but is not limited to:
6. Preparing submissions for review by the convened IRB
7. Assigning reviewers to submissions
8. Managing IRB meeting agenda volume
9. Confirming IRB member meeting attendance to ensure quorum
10. Monitoring quorum during IRB meetings
11. Documenting determinations made by the convened IRB
12. Generating IRB meeting minutes and correspondence
13. Providing regulatory guidance to the IRB Chair and members
14. Reviewing submissions in order to anticipate regulatory issues for which IRB members may need assistance (e.g., IND/IDE questions)
15. Serves as a resource to IRB Members, researchers and key personnel by providing support for the preparation of research applications, including guidance on applicable regulations, and subsequent submission in the electronic IRB protocol system.
16. Maintains D-H Collaborative Institutional Training Initiative (CITI) Training account and provides guidance to researchers and research staff needing assistance with CITI training.
17. Assists leaders in researching, developing, and conducting continuing education opportunities for the research community, ensuring continual and up-to-date awareness of the federal regulations which govern human subjects research.
18. Monitors, evaluates, and provides feedback to leaders regarding updates/edits needed to the D-H HRPP Toolkit and educational needs (deficiencies) of the IRB Committee, research community, and IRB staff.
19. Maintains current working knowledge of the regulations for the safety and protection of human subjects in research and stays current of any changes to the regulatory landscape that may affect the research community.
20. Performs other duties as required or assigned.

• Bachelor’s degree in a related field or the equivalent in education and experience with a minimum of two (2) years of directly related experience.



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



• Certified IRB Professional (CIP) Certification preferred



• Prior IRB experience preferred



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



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



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



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



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

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