Coordinator-Oncology Regulatory Affairs

Job Summary: The Coordinator-Oncology Regulation Affairs researches and ensures compliance with all Federal, State, local and other regulatory bodies, is responsible for maintaining all program regulatory files and documents, submits all protocol amendments, notices, suspensions, terminations, safety reports, and related protocol documents to the appropriate regulatory bodies within the expected timeframes. Performs other duties as needed. Performs other duties as needed.

Education and Experience: Associate's Degree in related field required. Experience may be considered in lieu of degree. Minimum of two years healthcare setting, oncology, clinical research, drafting or writing clinical documents experience preferred.

Knowledge and Skills: Read and write legibly; speak in English with professional quality; good interpersonal skills; maintain high level of confidentiality and ethical integrity; team player yet work independently with minimal supervision; work calmly and respond courteously when under pressure; organize and prioritize workload; manage multiple assignments effectively; accept direction; recall information with accuracy; pay close attention to detail; show critical independent thinking; make quick and informed decisions, detail-oriented. Use computer and software programs necessary to the position; perform basic math functions; distinguish colors and smells as necessary; hear sufficiently for general conversation in person and on the telephone; identify and distinguish various sounds associated with the work; see adequately to read computer screens and written documents necessary to position; discern temperature variances through touch.

Licensures and Certifications: Current Certified Clinical Research Coordinator (CCRC) required or achieved within one year of eligibility through Association of Clinical Research Professionals (ACRP).