Study Coordinator

Overview

It’s More Than a Career, It’s a Mission. Our people are the foundation of our success. By joining Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will be part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients globally. We seek mission-driven candidates who want to advance the fight against cancer and make a difference in patients’ lives.

Our Mission:
People who live with cancer—those who work to prevent it, fight it, and survive it—are at the heart of every decision we make. By bringing together innovative medical minds and passionate caregivers, SCRI is transforming care and personalizing treatment through clinical excellence and cutting-edge research.

Study Coordinator — you will plan, execute and monitor the completion of complex Phase I-IV clinical research protocols, including abstracting, assembling and organizing research data while ensuring adherence to the protocol and preparing reports. You will work closely with the physician principal investigator, manager of data operations, study sponsor and study team.

• Lead the execution of trials for the research team
• Plan and track all assigned clinical activity across startup, interim and close-out phases
• Confirm patient eligibility and discuss discrepancies with nursing staff and physicians
• Verify study procedures are performed within the protocol-specified windows
• Participate in sponsor teleconferences to update on patients, toxicity and overall response; notify department before and after calls to update study staff
• Present at weekly protocol meetings to investigators, research staff and management
• Provide pertinent safety information to sponsor and study teams by monitoring patient toxicity, including serious adverse events, per Common Toxicity Criteria
• Update internal research teams on protocol modifications and specifications (visit schedule, assessment windows, dose modifications, lab assessments)
• Create study-specific tools for source documentation (eligibility worksheets, screening checklists, vital signs, blood sampling as applicable)
• Ensure study tools and source documents are updated with amendments or study changes
• Investigate root causes of major protocol deviations and coordinate corrective and preventative actions
• Ensure pharmacy has Investigational Product and supplies
• Interface with laboratory personnel for lab kits and processing
• Track and report adverse events, serious adverse events, protocol waivers, deviations and violations
• Participate in monitor visits and review monitor letters within five business days of receipt; resolve open items
• Review source documentation and queries for missing data
• Collect, complete and enter data into study-specific case report forms or electronic data capture systems within contractually defined time frames
• Maintain case report forms tracking management database
• Review trial data for clinical relevance and raise medical issues to the research scientists and management
• Assist in physician oversight by updating on protocol issues and obtaining signatures for laboratory reports, ECGs and adverse events
• Assist in external sponsor audits and US FDA inspection preparation, conduct and closeout proceedings; review and respond to findings
• Maintain and archive study documentation and correspondence per company policy
• Report patient visit and data entry information in financial tracking systems
• Provide required metrics to leadership
• Initiate improvements to enhance efficiency and quality of work on assigned projects
• Adhere to professional standards and SOPs established for clinical research
• Assist internal quality team in preparation for sponsor and US FDA audits

• Understanding of clinical trial data
• Knowledge of FDA guidelines and GCP
• Ability to work independently in a fast-paced environment
• Strong interpersonal skills, detail-oriented and meticulous
• Computer skills with clinical trial databases, electronic data capture, MS Access or Excel
• Bachelor’s degree preferred
• At least one year of experience in healthcare, research or other science-related field
• At least one year of experience planning…