Senior Regulatory Coordinator

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversees regulatory supervision for clinical trials, encompassing the preparation and submission of amendments, ongoing reviews, safety reports, deviations, and study closure documentation to IRB, DSMC, PRMC, IBC, and other regulatory bodies, while ensuring adherence to institutional and federal regulations.

• Maintains precise and audit-ready electronic regulatory binders and essential study documents, guaranteeing continuous compliance with GCP, protocol specifications, regulatory standards, and internal policies during monitoring visits and external audits.

• Acts as the primary regulatory point of contact between investigators, research teams, sponsors, CROs, and regulatory agencies, facilitating prompt protocol approvals, addressing study-related inquiries, and providing submission status updates to key stakeholders.

• Offers regulatory expertise and operational direction to investigators and research personnel through onboarding, training, educational sessions, and the creation of reference materials concerning clinical trial policies, procedures, and compliance obligations.

• Works in collaboration with legal teams, sponsors, and study staff to review informed consent documents, ensuring consistency in institutional and contractual language, and implementing protocol and staffing modifications as needed.

• Engages in departmental meetings, process enhancement initiatives, and cross-functional workgroups to improve regulatory operations, bolster compliance practices, and support the efficient execution of clinical research programs.

⛳️ Requirements

• An associate degree with 5 years of experience in the management and execution of clinical trials in an academic environment, or a bachelor's degree with 3 years of relevant experience in the management and conduct of clinical trials in an academic setting.

• Familiarity with clinical trials, Federal, State, and Local Regulations, IRB requirements, as well as consent form and protocol development.

🏝️ Benefits

• Comprehensive Benefits