GENERAL SUMMARY OF POSITION:
Under the direction of the Director or designee, the Regulatory Specialist will facilitate clinical trial implementation and ensure regulatory compliance for the conduct of clinical research at UMMS/UMMHC.
Prepare initial Institutional Review Board (IRB) research applications for UMMS and UMMHC investigators to appropriate IRB systems such as eIRB, WIRB, CIRB
Prepare any subsequent submissions such as modifications, Reportable New Information (RNI), continuing reviews, study closures
Consult with study team with regard to the response to the IRB concerns
Submit the required regulatory documents to sponsors such as 1572s, financial disclosure forms (FDFs)
Prepare and maintain regulatory documents and binders for UMMS and UMMHC investigators
Maintain department “shared drive” in regards to regulatory files
Participate in internal quality assurance audits of research activities involving human subjects at UMMS and UMMHC
Provide guidance to investigators and coordinators regarding Good Clinical Practices (GCPs) in research involving human subjects
Provide guidance and assistance to investigators in preparing Investigational New Drug applications (INDs) and Investigational Device Exemptions (IDEs) to the Food & Drug Administration (FDA)
Act as liaison between investigator, sponsor and FDA personnel
Perform other duties as required.