Regulatory Coordinator will be responsible for all aspects of clinical research regulatory compliance, including document preparation, submission, and management, for a specified portfolio of clinical trials.
Coordinate the preparation and timely submission of regulatory documents to the local Institutional Review Board (IRB), Cancer Protocol Review and Monitoring Committee (CPRMC), Data Safety and Monitoring Board (DSMB), other internal committees, national cooperative groups, industrial clinical research sponsors, and Contract Research Organizations (CRO's) as necessary to meet all internal and external regulatory compliance standards. Responsibilities include, but are not limited to:
Initial review of research protocols and informed consent documents,
- Preparation and submission of protocol amendments, continuations, adverse events, and document addendums
- Assistance with FDA and NCI submissions in collaboration with other City of Hope departments and Regulatory Affairs Offices.
Assist in gathering information from Study Coordinators, Physicians, other staff, and study sponsors as needed for the submission of regulatory documents.
Assists Regulatory Manager with aspects of the research trials regulatory process to include:
- Prepare routine protocol status reports for the CTO office, Investigators, and research staff.
- Oversee and maintain documentation of correspondence to and from the IRB
- Assist COH researchers in study design, consent form creation and compliance with IRB requirements.
- Communicate to CTO staff relevant aspects of the regulatory process and requirements for protocol development and conduct of research trials.
Assist in maintaining master regulatory files in accordance with institutional, state and federal regulations.
Assist with updating the medical and CTO staff with regards to institutional requirements for protocol development and conduct of research trials.
1) Minimum of 6 months - 1 year of experience as a Regulatory Coordinator in a Clinical Research setting
2) Strong Communication Skills
3) Takes Initiative
4) Teamwork and Collaboration