Senior Regulatory Compliance Coordinator (Remote) - Tisch Cancer Center
About The Position
A Senior Regulatory Compliance Coordinator position is currently available within the Tisch Cancer Center. The incumbent will work with investigators and the Cancer Clinical Trials Office (CCTO) infrastructure to manage cancer clinical trials for the division. Duties include, but are not limited to, management of clinical studies through the regulatory portion of the trial submission process, ensuring regulatory integrity of assigned clinical trials from approval to closure, develop new clinical trials and act as the main contact during the protocol development phase, correspond with the reviewing committees and personnel, assist in budget development by identifying research non-billables, and coordinate start-up meetings for new protocols. The Senior Regulatory Compliance Coordinator will act as a mentor to junior staff— providing oversight and training to multiple study teams who develop and submit documentation and information for Institutional Review Board (IRB) review and who prepare and submit documents needed for regulatory and safety reporting to sponsors and other agencies. The Senior Regulatory Compliance Coordinator is a resource for Investigators and Research Teams. The position will report into the Assistant Director of Regulatory Compliance. Individuals should be comfortable with working in a team environment and will be expected to work collaboratively with investigators and administration. Cancer protocols include industry-sponsored, consortium, NCI projects, and investigator-initiated studies.
Requirements
- Comfortable with working in a team environment.
- Expected to work collaboratively with investigators and administration.
Responsibilities
- Manage cancer clinical trials for the division, working with investigators and the Cancer Clinical Trials Office (CCTO) infrastructure.
- Manage clinical studies through the regulatory portion of the trial submission process.
- Ensure regulatory integrity of assigned clinical trials from approval to closure.
- Develop new clinical trials and act as the main contact during the protocol development phase.
- Correspond with reviewing committees and personnel.
- Assist in budget development by identifying research non-billables.
- Coordinate start-up meetings for new protocols.
- Act as a mentor to junior staff, providing oversight and training to multiple study teams.
- Develop and submit documentation and information for Institutional Review Board (IRB) review.
- Prepare and submit documents needed for regulatory and safety reporting to sponsors and other agencies.
- Serve as a resource for Investigators and Research Teams.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
