Study Coordinator
Sarah Cannon Research Institute
Summary
As the Study Coordinator you will plan the execution and monitor the completion of complex Phase I-IV assigned clinical research protocols. Including abstracting, assembling and organizing research data while monitoring adherence to the clinical protocol and preparing reports on the data. Will work closely with the physician principal investigator, manager of data operations, clinical trial sponsor and study team.
Job description
- 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
- Present in weekly protocol meeting to investigators, research staff, and management
- 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 manage the follow 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 ensure 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 answer appropriate queries
- Apprise 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 respond to audit findings and escalate issues
- Maintain and archive study documentation and correspondence per company policy
- Report 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 SOPs established for clinical research
- Assist internal quality team in preparation for sponsor and US FDA audit teams
Requirements
- An understanding of clinical trial data
- Knowledge of FDA guidelines and GCP is required
- 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
- Bachelor Degree is preferred
- At least one year of experience in healthcare, research or other science related field
- At least one year of experience planning and managing clinical trial process
Benefits
- Comprehensive benefits
- Physical well-being support
- Mental well-being support
- Financial well-being support
- Competitive compensation package
- Annual bonus
- Long-term incentive opportunities
Company overview
Sarah Cannon Research Institute (SCRI) is a premier oncology research organization and global leader in community-based clinical trials. Founded in 2004 through a joint venture between Tennessee Oncology and Hospital Corporation of America, SCRI has established itself as one of the world's leading cancer research institutions. With headquarters in Nashville, Tennessee, the institute operates across more than 200 locations in over 20 U.S. states and the United Kingdom, bringing together more than 1,300 research physicians. SCRI specializes in conducting first-in-human clinical trials, having completed over 850 such studies since its inception, and has contributed significantly to the development of approximately 10 FDA-approved cancer therapies since 1999. The organization focuses primarily on oncology research while also expanding into cardiology, gastroenterology, and other therapeutic areas. SCRI's unique community-based model enables patients to access cutting-edge clinical trials close to home, bridging the gap between academic research centers and local healthcare providers. The institute employs 501-1,000 professionals and maintains strategic partnerships with pharmaceutical and biotechnology companies to advance cancer treatment innovations.