Regulatory Coordinator I - Cancer Clinical Trials Office

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The Regulatory Coordinator I prepares and submits protocols and supporting documents to regulatory bodies such as PRMC, IRB, and IACUC. This role submits continuations, amendments, responds to questions, generates reports, and maintains files research files and documentation involving the regulatory requirements for the study/clinical trial. Other duties include, representing the Medical Center when meeting with pharmaceutical companies, attending weekly team meetings, and working with other staff to insure all regulatory documents and requirements are met and up-to-date. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:

• Prepares and submits protocols and supporting documents to regulatory bodies such as PRMC, IRB, and IACUC.
• Submits continuations and amendments as necessary to maintain compliance with regulatory requirements and institutional policies.
• Responds to all questions from the IRB or IACUC related to the regulatory aspects of the study.
• Completes forms and generates all reports necessary to comply with regulatory requirements and institutional policies.
• Establishes and maintains research files and documentation pertaining to regulatory requirements for clinical trials.
• Meets with monitors from pharmaceutical companies and represents the Medical Center during these meetings.
• Works closely with the clinical trial coordinator, research staff, and investigators to assure that all regulatory documents for the research studies are up-to-date.
• Attends weekly research team meetings and updates staff and investigators on the status of regulatory submission and amendments.
• Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
• Maintains research practices using Good Clinical Practice (GCP) guidelines.
• Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Participates in required training and education programs.

DEPARTMENT AND/OR UNIT SPECIFIC - ESSENTIAL JOB RESPONSIBILITIES:

• Provide regulatory support for new and ongoing research studies. Includes but not limited to correspondence with institutional and federal regulators and study file documentation creation and maintenance.
• Ensure compliance of general and study specific regulatory related processes with SOPs, FDA, NIH, and applicable regulations for the reporting of events to regulatory agencies.
• Organize and store protocol files including but are not limited to: all protocol submission documents, correspondence from sponsor and study team, and responses/re-submissions.
• Assist in maintenance of regulatory-related internal tracking databases and filing systems. Assist in compilation of regulatory-related metrics for use by senior management.
• Participates in the pre-pending study management process including Confidentiality Disclosure Agreements (CDAs) and Feasibility Questionnaires (FQs).
• May attend Disease Research Group (DRG) meetings.
• Communication with study staff to ensure the maintenance and accuracy of the Delegation of Duties and Authority Log (DOAL). Ensure in conjunction with the DOAL that all subsequent training (whether initial or with a new study protocol amendment/modification) is completed for all study personnel and documentation maintained within the regulatory binder.
• Ensure all necessary forms are submitted to the trial sponsor and the IRB. Other duties as assigned by senior management.