Irb Coordinator
2 months ago
Overview:
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.
**Responsibilities**:
- 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.
- 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.
- Escalates matters of concern to the HRPP Director or IRB Manager as appropriate.
- Conducts non-committee review for certain submissions as determined by the HRPP Director or the IRB Manager.
- Prepares for, coordinates and facilitates IRB Committee meetings, which includes, but is not limited to:
- Preparing submissions for review by the convened IRB
- Assigning reviewers to submissions
- Managing IRB meeting agenda volume
- Confirming IRB member meeting attendance to ensure quorum
- Monitoring quorum during IRB meetings
- Documenting determinations made by the convened IRB
- Generating IRB meeting minutes and correspondence
- Providing regulatory guidance to the IRB Chair and members
- Reviewing submissions in order to anticipate regulatory issues for which IRB members may need assistance (e.g., IND/IDE questions)
- Maintains D-H Collaborative Institutional Training Initiative (CITI) Training account and provides guidance to researchers and research staff needing assistance with CITI training.
- 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.
- Performs other duties as required or assigned.
Qualifications:
- 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
- Knowledge of Microsoft Office Programs: Word, Excel, PowerPoint, Outlook; Internet Functions.
- 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.
Required Licensure/Certifications:
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