This position will support multiple clinical trials for the MFM Research Program under supervision of the Clinical Research Unit Project Manager. The primary role of this position is the organization, coordination, and implementation of 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 and coordinators to consent, enroll, assure protocol compliant treatment and assessments and follow-up patients for multiple clinical trials. The candidate must be enthusiastic and possess leadership qualities exhibited in a positive, team building demeanor, with demonstrated capability.
The essential functions of the position include but are not limited to: Construction of source documents, data collection and tabulation instruments and reports. 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 all aspects of clinical trial coordination including: subject enrollment, detailed data entry into multiple EDC systems, subject visits, (which includes scheduling of visits and clinical assessments according to protocol), follow-up and regulatory documentation (for SAEs and safety reporting). Work with program director to plan and lay groundwork for continued expansion of clinical trial menu. Actively troubleshoot and work as a positive problem solver in a large volume clinical setting to ensure full execution of 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.
Internal Number: 45981
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