Department: Oncology - GI Cancer Work Schedule/Hours: Monday-Friday/8:30-5:00pm
The Clinical Research Regulatory Specialist II will serve as a central resource for faculty conducting clinical research across multiple clinical trial sites. Working closely with the Principal Investigator, Study Coordinator, and IND Specialist, this position will ensure all proper regulatory documents have been collected, reviewed, and approved prior to the start of a study at satellite clinical trial sites. Will organize and assist the team in conducting the start-up meeting at each clinical trial site. Will be responsible for ensuring that each clinical trial site maintains accurate and up-to-date regulatory files through the duration of the clinical trial. This includes, but is not limited to implementation of protocol, Investigator's Brochure, and consent amendments, oversight of patient clinical trial registration, collection of adverse event and protocol deviation logs, and completion of trial monitoring/auditing requirements. Will also be responsible for coordinating teleconference calls with clinical trial sites.
Duties and Responsibilities: Work closely with the Principal Investigator, study coordinators, and the IND Specialist to ensure all regulatory documents are reviewed and approved prior to a study opening at satellite clinical trial sites. Organize the study start up meeting for studies where SKCCC is the coordinating center. Organize clinical trial site access to the trial database. Maintain accurate and up -to-date regulatory documents through the duration of the clinical trial. Correspond with clinical trial sites to ensure implementation of protocol, consent, and Investigator's Brochure amendments. Organize patient registration at each clinical trial site. Collect and organize adverse event and protocol deviation logs signed by each clinical trial site Principal Investigator. Coordinate teleconference calls with clinical trial sites, which includes generating a meeting agenda with updated enrollment and serious adverse events to be discussed and distributing meeting minutes. Develop standard operating procedures as needed. Assist SKCCC CRO in the auditing and monitoring of studies at clinical trial sites.
Bachelor's Degree related discipline. Must have at least 3 years of experience in academic or industry-based clinical research.
Special Knowledge, Skills, or Abilities / Competencies: Excellent verbal and communication skills are required. Must be a team player. Must have excellent prioritize skills. Must have familiarity with NIH, GCP, OHRP, and federal regulations for human subject participation in clinical research
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