Research Regulatory Coordinator

Prepare, complete, and submit required forms and documents to meet regulatory, IRB, and HIPAA guidelines during initial review, modifications, and continuing review. Perform Informed Consent review and modify consent forms and HIPAA language while working with sponsors and IRBs to conform to institutional guidelines. Complete, submit, and maintain regulatory documents including 1572s, delegation logs, and training records for industry-sponsored studies. Prepare for and participate in external sponsor/monitor visits and internal/external audits to ensure compliance and implement corrective action plans. Update protocol information on the Research website, distribute documents to researchers and PIs, and track study approvals and expirations. Maintain the regulatory database, manage electronic filings, and train staff on regulatory processes including CITI training and IRB submissions. Advise on remedies and revisions to resolve procedural issues ensuring timely IRB review, and notify staff of protocol activations and closures. Facilitate study closure in collaboration with investigators, research coordinators, and sponsors while applying rules and regulations to guide principal investigators in study activities. Monitor Investigator Initiated IRB-deferred studies, exempt, and non-engaged projects to ensure current regulatory documentation.