Serves as an expert for FCCC research community on all regulatory matters related to the NCI Clinical Trials Support Unit (CTSU); including but not limited to Cancer Therapy Evaluation Program (CTEP) annual registration which is required for all persons participating in any NCI-sponsored clinical trial. Sr NCI Regulatory Coordinator is responsible for the accurate compilation and s, modifications and continuing reviews for protocols funded by the National Institute of Cancer (NCI). The Sr NCI Regulatory Coordinator is responsible to submit the materials described above to the FCCC Institutional Review Board (IRB), the Central Institutional Review Board for the National Cancer Institute (CIRB) or any other single IRBs reviewing trials funded by NCI within the currently define time period as outlined in the NCI audit guidelines. The Sr NCI Regulatory Coordinator will also assist the NCI Quality Assurance Auditor with tracking submissions timelines and in designing, improving and implementing systems to ensure efficient processing and maintenance of all NCI regulatory documents.
In addition the Sr NCI Regulatory Coordinator is expected to interact with the institutional investigators, other members of the healthcare team, service line members in a manner, which supports the conduct of clinical trials.

Education
Bachelors Degree: Business, Healthcare or related field (Required)
Masters Degree in Business or a Healthcare related field (Preferred)
Combination of relevant education and experience may be considered in lieu of degree.
Licenses and Certifications
CCRP - Cert Clin Research Prof (Preferred)
RAC - Regulatory Affairs Cert (Preferred)
Experience
6 Years experience in a research or healthcare setting preferably oncology or clinical trials (Required)
2 Years experience in oncology clinical trials (Required)