Job Abstract

SUMMARY
The primary purpose of the Coordinator, Clinical Research Program is to support the clinical research activities and regulatory affairs of the Department of Gynecologic Oncology and Reproductive Medicine. Responsibilities include protocol development, research program support, and regulatory management.

Protocol Development and Processing:

• Responsible for preparing clinical research studies for submissions, amendments, monitoring and annual reviews according to institutional guidelines and systems.
• Develops, composes and revises clinical trial protocols and related documents in collaboration with study teams as required and ensures protocols meet regulatory requirements; composes accompanying correspondence for protocol amendments.

· Utilizes technical writing skills to compose and abstract medical and scientific information for preparation of written correspondence, reports, and other documents under the direction of study investigators, managers/supervisors.

· Interacts with protocol sponsors (FDA submissions group, industry, government, and cooperative groups).

· Knowledgeable regarding pharmaceutical protocol submission process, formatting requirements, deadlines, and regulatory issues.

· Manages the review and approval process for clinical trial protocols and amendments, including submitting documents to Institutional Review Boards (IRBs) and regulatory authorities.

· Communicates with study teams and investigators to ensure that study protocols are executed as designed and within the approved timeline.

· Maintains accurate and up-to-date records of protocol development and processing activities; ensures all regulatory and institutional requirements are met before study activation.

Research Program Support:

· Provides administrative support for program activities and projects for the department’s Clinical Research Program.

· Attends departmental research program meetings to assist in providing oversight and/or support for all designated site-specific research programs and committees.

· Works closely with Program Management to prepare data, reports, and other information for departmental or program meetings.

· Maintains and updates shared/common documents in cloud networks (e.g. OneDrive, Microsoft Teams, Prometheus, etc.)

· Serves administrative lead for departmental groups, committees, etc., as assigned

· Provides logistical coordination for trial-related activities, such as tissue collection and data transfer.

· Acts as a program resource for matters related to protocol issues.

· Develops and maintains a comprehensive understanding of regulatory requirements, including FDA regulations, ICH guidelines, and local regulations, and ensures compliance with these regulations.

Regulatory Management:

· Submits protocol amendments and associated documents to the research committees (e.g. IRB and SRC) and tracks submission status.

· Composes the correspondence accompanying protocol submissions and ensures that the submissions are prepared properly.

• Ensures all steps required for activation and maintenance of protocols in required institutional systems are completed (e.g. ePRTCL, OnCore, eReg, etc.) for assigned protocols.

· Maintains regulatory files. Ability to develop and maintain a tracking system for all protocol related paperwork.

· Interacts and provides appropriate correspondence to industry trial monitors, IND office monitors and institutional auditors.

· Addresses continuing review and/or CRC/PBHSRC/IRB contingencies or forwards to the study manager or Principal Investigator for completion.

· Forwards copies of IRB approval memos to required organizations (NCI, CRO, pharmaceutical companies, etc.) as needed.