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Research Compliance Associate

2 months ago

Duarte, California, United States City of Hope Full time
Position: Clinical Research Regulatory Coordinator - Remote
The Clinical Trial Office (CTO) plays a pivotal role in supporting investigators at City of Hope in managing research studies involving human subjects.

Under the guidance of the Portfolio Supervisors, Senior Director of the Clinical Trial Office, and the CTO leadership team, along with contributions from Disease Team Chairs and Study Investigators, the CTO staff coordinates various activities to facilitate multiple research studies across all phases.

The Clinical Research Regulatory Coordinator is tasked with the submission of studies through various regulatory committees, including scientific review and Institutional Review Board (IRB) review.

This role acts as a liaison with the different IRBs that oversee City of Hope research, including but not limited to City of Hope, Western IRB, Central IRB of the National Cancer Institute, Schulman IRB, and any other IRB that may establish an agreement with City of Hope.

The coordinator collaborates with investigators and sponsors to address oversight committee conditions and requests for additional information.

City of Hope utilizes the Integrated Research Information System (iRIS) for electronic protocol submissions and OnCore as the Clinical Trials Management System (CTMS).

This position is essential for ensuring regulatory compliance with the research protocol and adherence to all relevant regulations.

Key Responsibilities:

Protocol Management:
Maintain up-to-date knowledge of institutional protocol submission procedures, track protocol documentation, and gather necessary information for submissions.

Submission Coordination:
Prepare and submit new studies to relevant committees, draft and edit informed consent documents, and ensure timely protocol approvals.

Communication:

Keep the Senior Regulatory Coordinator, RSS Manager, Principal Investigator, and research staff informed about protocol status, while also communicating with internal reviewers and external agencies.


Regulatory Compliance:

Prepare and submit revisions (amendments, continuing reviews, deviations) to the appropriate committees, ensuring compliance with institutional, state, and federal regulations.


Documentation:
Maintain Regulatory Binders for each study, update FDA Forms 1572 and Financial Disclosures, and coordinate regulatory correspondence.

Qualifications:
A Bachelor's degree is required.

At least one year of experience related to the management and execution of clinical trials in an academic environment, or six months of experience as a Project Coordinator or Biospecimen Coordinator within the CTO.

A working knowledge of clinical trials, as well as Federal, State, and Local Regulations, IRB requirements, consent form, and protocol development is essential.
City of Hope is committed to equal opportunity employment. To learn more about our dedication to diversity, equity, and inclusion, please refer to our resources.
For more information on our Comprehensive Benefits, please explore our offerings.

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