Regul

Regulatory Coordinator

Location:

United States

Category:

Clinical Trials Operations

Job Type:

Full-time

Pay Rate:

$34.64 – $53.70 per hour

As a Regulatory Coordinator at City of Hope, you’ll play a crucial role in assisting our investigators with the submission of human subject research to regulatory committees, contributing to the advancement of critical medical research. Reporting to the Portfolio Supervisors, Senior Director, Clinical Trial Office, and the CTO leadership team, you’ll facilitate prompt protocol submissions, serving as a liaison to external IRBs.

As a successful candidate, you will:

New Research Study Submission:

• • Develop and maintain knowledge of institutional protocol submission procedures.
  • Coordinate the preparation and submission of new studies to appropriate committees.
  • Keep stakeholders informed of protocol approval and activation status.

Post Initial Approval Submissions:

• • Prepare and submit amendments, continuing reviews, and deviations to appropriate committees.
  • Participate in research audits and communicate status to the PI and research staff.

Regulatory Documents:

• • Assist in maintaining Regulatory Binders for each study.
  • Liaise with Protocol Coordinators, investigators, and sponsors.
  • Attend meetings, conferences, and contribute to the training of new clinical trials staff.

Qualifications

Your qualifications should include:

• Bachelor’s degree.
• Two or more years of experience related to the management and conduct of clinical trials in an academic setting.
• Working knowledge of clinical trials, Federal, State, and Local Regulations, IRB requirements, consent form, and protocol development.