Clinical Trial Lead, Phase I-IV Coordination

Tennessee Oncology; Nashville (TN); On-site; USD 55,000 - 75,000; Full time

Job summary

Tennessee Oncology is seeking a detail-oriented clinical research professional to coordinate and manage Phase I-IV trial activities. You will ensure adherence to Good Clinical Practice (GCP) and regulations, support cross-functional teams, and oversee patient eligibility and study documentation.

The role involves site visits, data management, and close collaboration with investigators, study sponsors, and clinical staff to maintain trial quality and patient safety.

Qualifications

• Ability to independently handle multiple priorities in a fast-paced environment.
• Ability to comprehend complex clinical trial protocols.
• Microsoft Office product knowledge (Word, Excel, PowerPoint, SharePoint, OneNote).

Responsibilities

• Manage day-to-day operations of complex Phase I-IV clinical research protocols in compliance with GCP/ICH and regulatory requirements.
• Lead cross-functional study teams and coordinate activities with preclinical, pharmaceutical sciences, safety, and regulatory affairs.
• Perform second checks for patient eligibility following nurse review, including inclusion/exclusion criteria.
• Attend Site Initiation Visits and monitor visits; manage study documentation and timelines.
• Maintain informed consent records and trial documents throughout the study lifecycle.
• Provide regular updates on timelines, patient status, and trial details to study teams and sponsors.
• Assist with data entry and ensure data integrity and quality.
• Maintain patient rights, safety, and welfare and uphold confidentiality.

Skills

Multi-tasking

Understand complex protocols

MS Office proficiency

Education

Bachelor's degree or equivalent

Job description

Tennessee Oncology is seeking a detail-oriented clinical research professional to coordinate and manage Phase I-IV trial activities. You will ensure adherence to Good Clinical Practice (GCP) and regulations, support cross-functional teams, and oversee patient eligibility and study documentation.

The role involves site visits, data management, and close collaboration with investigators, study sponsors, and clinical staff to maintain trial quality and patient safety.