Research Regulatory Coordinator

NOW HIRING FOR AN RESEARCH REGULATORY COORDINATOR WITH A LOCAL HEALTHCARE FACILITY IN SAVANNAH, GA!

Position: Research Regulatory Coordinator
Shift Monday – Friday 7:30 – 4:00 pm Length of Assignment: 4-6 months
Start Date: ASAP Hourly
Rate: $24

Job Duties as a Research Regulatory Coordinator:

• The Research Regulatory Coordinator is responsible for coordinating regulatory documents including submissions for new National Cancer Institute protocols, amendments, consent forms, safety adverse event reports, 1572 forms, financial disclosures, investigator CVs, training certificates and other related cancer research study documents for submission.
• Complies with all policies, procedures, departmental guidelines, and applicable laws in the conduct of routine activities and the solution of problems; prepares documents for regulatory review, monitoring and auditing.
• Ensures that all regulatory documents are in compliance and maintained in accordance with Good Clinical Practice (GCP), Department of Health and Human Services (DHHS), and the Food and Drug Administration (FDA) guidelines.
• Works independently to assure compliance with the requests of sponsors, and internal managers and directors as needed.
• Works with the Clinical Research Coordinators (CRC) in conducting monitoring visits, responding to monitoring reports, audit reports and additional research protocol duties as needed.
• Maintains sponsor, investigator and research personnel regulatory communication and serve as primary contact for all NCI and Pharmaceutical IRB and regulatory correspondence with sponsors and cooperative groups.

• The Research Regulatory Coordinator is responsible for coordinating regulatory documents including submissions for new National Cancer Institute protocols, amendments, consent forms, safety adverse event reports, 1572 forms, financial disclosures, investigator CVs, training certificates and other related cancer research study documents for submission.
• Complies with all policies, procedures, departmental guidelines, and applicable laws in the conduct of routine activities and the solution of problems; prepares documents for regulatory review, monitoring and auditing.
• Ensures that all regulatory documents are in compliance and maintained in accordance with Good Clinical Practice (GCP), Department of Health and Human Services (DHHS), and the Food and Drug Administration (FDA) guidelines.
• Works independently to assure compliance with the requests of sponsors, and internal managers and directors as needed.
• Works with the Clinical Research Coordinators (CRC) in conducting monitoring visits, responding to monitoring reports, audit reports and additional research protocol duties as needed.
• Maintains sponsor, investigator and research personnel regulatory communication and serve as primary contact for all NCI and Pharmaceutical IRB and regulatory correspondence with sponsors and cooperative groups