Study Coordinator

Sarah Cannon Research Institute • Nashville, TN

3d

About The Position

The Study Coordinator plans the execution and monitors completion of complex Phase I–IV clinical research protocols. The role assembles and organizes research data, monitors protocol adherence, and prepares data reports. The Study Coordinator works closely with the physician principal investigator, manager of data operations, clinical trial sponsors, and the study team, and leads trial execution for the research team.

The role oversees study activities through startup, interim, and closeout phases; coordinates patient eligibility and protocol procedures; monitors patient safety and trial data; and supports sponsor communications, monitoring visits, audits, and inspections. The Study Coordinator also maintains study documentation and tracking systems, reports metrics and financial-tracking information, and identifies improvements to the efficiency and quality of assigned projects. The position requires adherence to professional standards and clinical research SOPs.

Requirements

• Understanding of clinical trial data.
• Knowledge of FDA guidelines and Good Clinical Practice (GCP).
• Ability to work independently in a fast-paced environment.
• Strong interpersonal skills and a detailed-oriented, meticulous approach.
• Computer skills, including ability to use clinical trial databases, electronic data capture, MS Access, or Excel.
• 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.

Nice To Haves

• Bachelor’s degree preferred.

Responsibilities

• Lead execution of trials for the research team.
• Plan and track assigned clinical activity throughout 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 windows.
• Participate in sponsor teleconferences to provide patient updates, including research visits, toxicity, and overall response; notify department staff before and after calls.
• Present at weekly protocol meetings with investigators, research staff, and management.
• Monitor patient toxicity, including serious adverse events, and provide relevant safety information to sponsors and study teams according to Common Toxicity Criteria.
• Update internal research teams on 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, including eligibility worksheets, screening checklists, and worksheets for vital signs and blood sampling.
• Investigate the root causes of major protocol deviations and manage follow-up with responsible departments for corrective and preventive actions.
• Ensure the pharmacy has 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 each assigned trial.
• Review and comment on monitor letters within five business days of receipt and ensure open items are resolved.
• 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 agreed timeframes; maintain the case report forms tracking database.
• Review trial data for clinical relevance and respond to appropriate queries; inform research scientists and management of study-specific medical issues for guidance.
• Support 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 processing for external 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.
• Report 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.
• Adhere to clinical research professional standards and SOPs; assist the internal quality team in preparing for sponsor and US FDA audits.

Benefits

• Comprehensive benefits supporting physical, mental, and financial well-being.
• Competitive compensation package; an annual bonus or long-term incentive opportunities may also be offered.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: No Education Listed