Oncology Clinical Trials Study Coordinator - Lead & Execute

Sarah Cannon Research Institute (SCRI); Nashville (TN); On-site; USD 55,000 - 90,000; Full time

Job summary

Sarah Cannon Research Institute (SCRI) is seeking a Study Coordinator to plan and monitor complex Phase I-IV clinical trials. You will work closely with investigators, data operations, and sponsors to ensure protocol adherence and timely reporting.

Responsibilities include trial startup activities, patient eligibility verification, data entry, and monitoring for safety events according to regulatory guidelines. A Bachelor’s degree and clinical research experience are preferred.

Qualifications

• 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 and 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.

Responsibilities

• 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 sponsor teleconferences to update on patients including research visits, toxicity, and overall response.
• Present in 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, 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).

Skills

Clinical trial data

FDA guidelines

GCP knowledge

Independent worker

Interpersonal skills

Attention to detail

Trial databases

EDC software

Education

Bachelor degree

Tools

MS Access

Excel

EDC software

Job description

Sarah Cannon Research Institute (SCRI) is seeking a Study Coordinator to plan and monitor complex Phase I-IV clinical trials. You will work closely with investigators, data operations, and sponsors to ensure protocol adherence and timely reporting.

Responsibilities include trial startup activities, patient eligibility verification, data entry, and monitoring for safety events according to regulatory guidelines. A Bachelor’s degree and clinical research experience are preferred.