Study Coordinator

Study Coordinator at MCKESSON

• plan the execution and monitor the completion of complex Phase I-IV assigned clinical research protocols
• abstracting, assembling and organizing research data while monitoring adherence to the clinical protocol and preparing reports on the data
• lead the execution of trials for the research team
• plan and track all assigned clinical activity in the lifecycle phases of the startup, interim and close out
• confirm patient eligibility and discuss discrepancies with nursing staff and physicians
• verify study procedures are performed within the protocol specified window
• participate in teleconferences with sponsors to update on patients including research visits, toxicity, and overall response
• provide pertinent safety information to sponsor and study teams by monitoring patient toxicity, including serious adverse events, on trial according to Common Toxicity Criteria
• update internal research teams on protocol modifications and specifications including visit schedule, assessment windows, dose modifications, central and local laboratory assessments
• create study specific tools for source documentation including eligibility worksheets, screening checklists and worksheets capturing vital signs, blood sampling (as applicable)
• ensure study specific tools, including source documents (including paper and/or EMR), are updated with any amendment(s) or study changes
• investigate root cause of major protocol deviations and manages the follows up with responsible departments for corrective and preventative actions
• ensure pharmacy has Investigative Product and supplies
• interface with laboratory technician for lab kits and processing
• track and report adverse events, serious adverse events, protocol waivers, deviations and violations
• participate in monitor visits for each assigned trial at each monitoring visit
• review and comment on monitor letters within 5 business days of receipt and insures resolution of open items
• review source documentation and queries for missing documentation
• collect, complete and enter data into study-specific case report forms or electronic data capture systems within the contractually agreed upon timeframe
• maintain case report forms tracking management database
• review trial data for clinical relevance and answers appropriate queries Apprises research scientists and management team of all study specific medical issues for guidance
• assist in ensuring physician oversight by updating on protocol issues and obtaining signatures and clinical significance of laboratory reports, ECGs, and adverse events
• assist in external sponsor audit and US FDA inspection preparation, conduct, and close out processioning
• review and responds to audit findings and escalates issues
• maintain and archive study documentation and correspondence per company policy
• reports patient visit and data entry information in financial tracking system
• provide required metrics to leadership
• initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects
• adhere to professional standards and SOP’s established for clinical research

• Understanding of clinical trial data
• Knowledge of FDA guidelines and GCP
• The ability to work independently in a fast-paced environment
• Interpersonal skills, detailed-oriented and meticulous
• Computer skills with ability using clinical trial databases, electronic data capture, MS Access or Excel

• 401k matching
• Health insurance
• Flight privileges

Sarah Cannon Research Institute (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials.