CLINICAL RESEARCH COORD B
Duties: This position will support multiple clinical trials for the GYN Oncology Research Program under supervision of the Director of Clinical Research Operations. The primary role of this position is the organization, coordination, and implementation of all regulatory functions related to multiple clinical trials, including those sponsored by pharma, investigator initiated and NCTN studies. The individual will be responsible for working with a team of nurses, coordinators and data mangers to ensure regulatory compliance with the FDA, sponsors, CROs and all internal monitoring groups for multiple clinical trials in the Division of Gyn Oncology. He/She will be responsible for the preparation and tracking of and the planning for IRB, CTSRMC, radiation safety, bioethics committee and all other reviewing entity submissions for new and existing clinical trials. The candidate must be enthusiastic and possess leadership qualities exhibited in a positive, team building demeanor, with demonstrated capability of same.
The essential functions of the position include but are not limited to: Responsibility for all aspects of clinical trial regulatory compliance, including: IRB submission preparation and review, CTSRMC submissions, bioethics committee review submissions, CHTN applications, follow-up and regulatory documentation (for SAEs and safety reporting) for multiple clinical trials in Gyn Oncology, Present monthly study updates at clinical trials meetings, and update clinical data bases in real time, including sharepoint and Velos. Provide clinical services, including phlebotomy and biospecimen processing and shipping. Has investigational product accountability, including working with IDS and IVRS/IWRS systems, documentation and delivery to subjects, providing and collecting and recording drug diaries/calendars. Prepare for and participate in monitoring visits and audits. Preparation of progress reports for yearly regulatory continuing review.
Will be responsible for follow-up and regulatory documentation (for SAEs and safety reporting) working with program director to plan and lay groundwork for upcoming expansion of clinical trial menu. Actively troubleshoot and work as a positive problem solver in a large volume clinical setting to ensure full regulatory compliance for all protocols. Responsible for assisting in clinical trial start up, including but not limited to the development of electronic templates for protocol treatment of oncology patients, constructing prospective reimbursement analysis with supporting documentation, obtaining Research Billing Numbers, scheduling and participating in site qualification and initiation visits.
Qualifications: Bachelor's degree and 2 years to 4 years of experience or equivalent combination of education and experience required. The candidate must be enthusiastic and possess leadership qualities exhibited in a positive, team building demeanor, with demonstrated capability of same. Knowledge of women's health and medical charts are required. Working and facile knowledge Microsoft office, particularly Power Point and Excel required.
Reference Number: 40-28513
Salary Grade: 026
Employment Type: Exempt
Org: WM-Ctr for Res on Reprod and Women's Health
Job Family: I-Technical/Professional Research