Clinical Trial Specialist

Tennessee Oncology, one of the nation’s largest community-based cancer care specialists, has been serving patients since 1976. Our mission is to provide high-quality cancer care and the expertise of clinical research at convenient community locations. We are looking for a Clinical Trial Specialist I to support our research team by coordinating the approval processes and conduct of research protocols, ensuring integrity and quality of research in compliance with Good Clinical Practice (GCP), federal and sponsor regulations, GHCR policies, and study protocols. The specialist will assist in the management of subjects, coordinate activities under guidance of a Clinical Trial Specialist II, and help maintain compliance with regulatory requirements. ESSENTIAL FUNCTIONS: 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 research nurse, including a second check 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 of 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 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 would affect, and impact, other areas related to the own job area/team with occasional guidance. KNOWLEDGE, SKILLS & ABILITIES: 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, and OneNote). EDUCATION & EXPERIENCE: Bachelor’s Degree or equivalent combination of education and experience required. One year of experience working in clinical trials required. #J-18808-Ljbffr Astera Cancer Care