Associate Regulatory Coordinator-Remote

The Clinical Trial Office (CTO) assists COH investigators with the management of research studies involving human subjects. Under the direction of the Portfolio Supervisors, Senior Director, Clinical Trial Office and the CTO leadership team with input from the Disease Team Chairs and the Study Investigators, the staff of the CTO coordinates activities to support multiple research studies of all phases.

The Associate Regulatory Coordinator is responsible for submission of studies through the various regulatory committees, including scientific review and IRB review. The Associate Regulatory Coordinator serves as the liaison with the various IRBs who review COH research including City of Hope, Western IRB, Central IRB of the National Cancer Institute, Schulman IRB and any other IRB that may enter into an agreement with COH. They work with investigators and sponsor to address oversight committee conditions and requests for information. COH uses Integrated Research Information System (iRIS) as its electronic protocol submission system as well as OnCore as our Clinical Trials Management System (CTMS). This tract is responsible for ensuring regulatory compliance to the research protocol, adhering to all appropriate regulations.

As a successful candidate, you will:

• Protocol Management: Maintain knowledge of institutional protocol submission procedures, track protocol paperwork, and collect criteria information for submissions.
• Submission Coordination: Prepare and submit new studies to relevant committees, draft/edit informed consent documents, and ensure timely protocol approval.
• Communication: Inform and update the Senior Regulatory Coordinator, RSS Manager, PI, and research staff about protocol status, and communicate with internal reviewers and external agencies.
• Regulatory Compliance: Prepare and submit revisions (amendments, continuing reviews, deviations) to appropriate committees, and comply with institutional, state, and federal regulations.
• Documentation: Maintain Regulatory Binders for each study, update FDA Forms 1572 and Financial Disclosures, and coordinate regulatory correspondence.

Your qualifications should include:

• Bachelor’s degree.
• At least one year of experience related to the management and conduct of clinical trials in an academic setting, or six months experience as a Project Coordinator or Biospecimen Coordinator in the CTO. Working knowledge of clinical trials, Federal, State, and Local Regulations, IRB requirements, consent form and protocol development.

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