Research Regulatory Coordinator

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This position will oversee all regulatory affairs business for researchers within Arkansas Children’s Research Institute. This individual will support researchers ensuring that research protocols involving human subjects abide by the federal regulation, state codes, IRB oversight standard, and the institutional policies governing human subjects research.

1. Prepares and submits IRB documents under the direction of the PI/Research Administrator and prepares regulatory documents to be sent to the Sponsor. Assists with submitting documents and contracts through regulatory and IRB processes and approval; may draft various communications with Sponsor.

2. Performs high quality review of start-up regulatory forms and associated documentation prior to submission to sponsor, IRB and filing in Regulatory Binders, to assure documents meet all site and sponsor requirements.

3. Coordinates and participates in the pre-site and, site initiation visits and Interim Monitoring Visits as required per protocol. Planning and design of source documents for protocols.

4. Manages and proofreads updated study regulatory drafts to ensure the accuracy and completeness of changes. Utilizes data resources external to research area, as well as develops and facilitates productive working relationship with the study monitors.

5. Compliance with all Office of Compliance, and any other departmental training requirements.

6. Communicate to researchers and research team members review board decisions or compliance issues which may negatively impact the future of their research protocols.

7. Negotiate revisions with researchers and sponsors to facilitate research review board consideration and approval to ensure regulatory compliance. (Understand the IRB’s operational requirements)

8. Communicate to researchers and research team members review board decisions or compliance issues which may negatively impact the future of their research protocols. Monitor compliance of research investigators as to provisions and directions given by the review board regarding research protocols

9. Attends and participates in conferences which support the objectives and goals of the specific protocols.
b. Actively participates in study related meetings.
c. Participates in educational programs and professional activities to gain knowledge of current trends, practices and developments.