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 to the St. Joseph's/Candler (SJ/C) Institutional Review Board (IRB) and the National Cancer Center (NCI) Central Institutional Review Board Central (CIRB) as appropriate.

Complies with all SJ/C 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, SJ/C IRB 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.

Education
:
Bachelors of Healthcare - Required

Experience
: 2-3 Years Regulatory environment - Preferred, GCP or CRA training - Preferred

License & Certification
:
None Required

• Maintain Regulatory Binder for each clinical trial and prepares documents for IRB and/or sponsor.
• Ensures all annual renewals are submitted and approved in a timely manner.
• Other trial-related documents are processed timely.
• Maintain historical and current database for clinical trials utilizing CREDIT software and other as appropriate