Clinical Trial Specialist

About the Organization

Tennessee Oncology, established in 1976 in Nashville, is one of the nation’s largest community-based cancer care specialists and home to one of the leading clinical trial networks in the country. Our mission is to provide access to high-quality cancer care and the expertise of clinical research for all patients at convenient community locations. We are committed to advancing the science of detection and targeted treatments, making these advances available to every patient.

About the Role

This position works closely with the research team to coordinate the approval processes and conduct of research protocols, ensuring the integrity and quality of the research is maintained. The Clinical Trial Specialist I will assist in managing subjects on clinical trials and coordinating activities under the mentorship of a Clinical Trial Specialist II, adhering to Good Clinical Practice Guidelines, federal and sponsor regulations, GHCR policies, and research protocols.

Responsibilities

• Manage and execute the day-to-day operations of complex Phase I-IV clinical research protocols in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
• Manage and lead cross-functional study teams, including vendors; liaise with other functional areas (preclinical development, pharmaceutical sciences, safety, and regulatory affairs) to coordinate clinical study activity.
• Provide a second check for patient eligibility to clinical trials, following review by a research nurse, including verification of inclusion/exclusion requirements and eligibility criteria.
• Attend and oversee Site Initiation Visits.
• Coordinate and attend regular monitoring visits and closeout visits.
• Maintain informed consent records for each patient for the duration of a study.
• Maintain and file all relevant study documents throughout the lifetime of a trial.
• Provide regular and concise updates on study timelines, patient statuses, and trial details to study teams, Principal Investigator, and study sponsor.
• Meet data management deadlines set by internal and external teams.
• Act as a point of contact for the Research Data Coordinator, assisting with and reviewing data entry where necessary.
• Protect the rights, safety, and welfare of patients.
• Strive to maintain harmonious relationships with clinic personnel, clients, and administrative staff.
• Review newly activated protocols, amendments, notices, suspensions, and terminations.
• Maintain required certification in Good Clinical Practice and Good Documentation Practice.
• Serve as a liaison to multiple Tennessee Oncology departments, providers, and other personnel.
• Serve as a liaison between GHCR and external clients and sponsors.
• Maintain a professional approach respecting the dignity and confidentiality of patients.
• Maintain a good attendance record and report to work on time.
• Maintain a professional attitude and appearance.
• Proactively identify trial-related issues and provide recommendations for resolution.
• Execute job responsibilities with an understanding of how output impacts other areas related to own job area/team with occasional guidance.

Requirements

• Bachelor’s Degree or equivalent combination of education and experience required.
• One year of experience working in clinical trials required.

Skills

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