The Research Regulatory Coordinator is a specialized research professional that facilitates and coordinates the regulatory aspects of a clinical trial and plays a critical role in the conduct of research at Carle. This role is responsible for preparing, completing, and submitting required forms and documents, in consultation with the research team, to meet regulatory, IRB, and HIPAA guidelines and policies, at the time of initial review, modifications, and continuing review. The Research Regulatory Coordinator also manages IRB-deferred studies, exempt and non-engaged projects by establishing and maintaining a direct line of communication with Carle and external investigators and/or research teams. The Regulatory Coordinator performs Informed Consent review and modifies consent form/HIPAA language while working with sponsors and IRBs for all studies to conform to Carle institutional guidelines.
- Prepares, completes, and submits required forms and documents, in consultation with the research team, to meet regulatory, IRB, and HIPAA guidelines and policies, at the time of initial review, modifications, and continuing review.
- Manages IRB-deferred studies, exempt and non-engaged projects by establishing and maintaining a direct line of communication with Carle and external investigators and/or research teams
- Initiates regulatory communication and facilitates regular ongoing communication between investigators and SFCRI
- Serves as the "point-person" for the UIUC or other external investigators for IRB-deferred studies and would be the main contact at Carle for initiating any future changes to their research that may impact or change their engagement with Carle
- Monitoring IRB-deferred studies for continuing IRB review including modifications and annual approvals by ensuring regulatory documentation is current and maintained
- Updating and maintaining in the CTMS the active informed consent documents and HIPAA authorizations that are being utilized in projects in which subjects are consented (whether Carle research is assisting with consenting or not)
- Reviews and critiques protocols for operational compliance, in collaboration with the research team
- Advises on remedies and revisions, in collaboration with the coordinator and/or investigator, and resolves any procedural issues that might arise in order to ensure timely IRB review
- Performs Informed Consent review and modifies consent form/HIPAA language while working with sponsors and IRBs for all studies to conform to Carle institutional guidelines
- Ensures consent language matches the research contract, budget, and protocol
- Submits site specific modifications to NCI CIRB as needed per study
- Acts as NCI CIRB designated signer for IRB submissions
- Notifies appropriate staff, physicians, investigators and affiliates of protocol activations and closures in a timely manner
- Facilitates study closure in collaboration with investigator, research coordinator, and sponsor
