Study Coordinator

Sarah Cannon Research Institute•Nashville, TN

About The Position

The Study Coordinator plans the execution and monitors completion of assigned Phase I–IV clinical research protocols. The role organizes research data, monitors adherence to protocols, and prepares data reports, working closely with the physician principal investigator, data operations manager, clinical trial sponsors, and study team. The coordinator leads trial execution for the research team and tracks clinical activity through startup, interim, and closeout phases. Responsibilities include confirming patient eligibility; coordinating protocol-specified procedures and visits; monitoring and reporting patient toxicities and safety events; communicating protocol changes and study requirements; maintaining study-specific source documentation and case report forms; managing queries, deviations, and corrective actions; coordinating sponsor monitoring visits and audit or inspection preparation; maintaining study records; and reporting visit, data-entry, and performance metrics. The coordinator is expected to follow clinical research professional standards and established SOPs and to identify improvements to the efficiency and quality of assigned work. Sarah Cannon Research Institute is a community-based oncology research organization focused on advancing therapies and expanding access to clinical trials. It is part of McKesson and offers a Total Rewards package intended to support colleagues’ physical, mental, and financial well-being. Compensation is determined by factors including performance, experience, skills, equity, and geographic market; an annual bonus or long-term incentive opportunities may also be offered.

Requirements

At least one year of experience in healthcare, research, or another science-related field.
At least one year of experience planning and managing the clinical trial process.
Understanding of clinical trial data.
Knowledge of FDA guidelines and Good Clinical Practice (GCP).
Ability to work independently in a fast-paced environment.
Interpersonal skills and a detailed-oriented, meticulous approach.
Computer skills, including the ability to use clinical trial databases, electronic data capture systems, MS Access, or Excel.

Nice To Haves

Bachelor’s degree preferred.

Responsibilities

Lead execution of assigned clinical trials for the research team.
Plan and track assigned clinical activity across study startup, interim, and closeout phases.
Confirm patient eligibility and discuss discrepancies with nursing staff and physicians.
Verify that study procedures are performed within protocol-specified time windows.
Participate in sponsor teleconferences and provide updates on patient research visits, toxicity, and overall response; notify department staff before and after calls.
Present study updates at weekly protocol meetings with investigators, research staff, and management.
Monitor patient toxicity, including serious adverse events, and provide pertinent safety information to sponsors and study teams according to Common Toxicity Criteria.
Update internal research teams about protocol modifications and specifications, including visit schedules, assessment windows, dose modifications, and central and local laboratory assessments.
Create and update study-specific source documentation tools, such as eligibility worksheets, screening checklists, and worksheets for vital signs and blood sampling.
Investigate root causes of major protocol deviations and coordinate corrective and preventive action follow-up with responsible departments.
Ensure the pharmacy has the investigational product and supplies, and coordinate with laboratory technicians regarding lab kits and processing.
Track and report adverse events, serious adverse events, protocol waivers, deviations, and violations.
Participate in monitor visits for assigned trials and review monitor letters within five business days, ensuring open items are resolved.
Review source documentation and queries for missing documentation; collect, complete, and enter data into case report forms or electronic data capture systems within agreed timeframes.
Maintain the case report form tracking management database, review trial data for clinical relevance, and answer appropriate queries.
Inform research scientists and management of study-specific medical issues and assist with physician oversight by communicating protocol issues and obtaining signatures and clinical significance assessments for laboratory reports, ECGs, and adverse events.
Assist with preparation, conduct, and closeout of sponsor audits and US FDA inspections; review and respond to audit findings and escalate issues.
Maintain and archive study documentation and correspondence according to company policy.
Record patient visit and data-entry information in the financial tracking system and provide required metrics to leadership.
Initiate improvements to enhance the efficiency and quality of work on assigned projects.
Follow professional standards and SOPs established for clinical research, and assist the internal quality team in preparing for sponsor and US FDA audits.