Clinical Trial Specialist

Clinical Trial Specialist The Clinical Trial Specialist supports the compliant and efficient execution of Phase I–IV oncology clinical trials by serving as the operational and regulatory lead for active protocols. This role focuses on protocol execution, regulatory oversight, data quality, and sponsor‑facing trial management. Key Responsibilities Manage daily operations of active oncology clinical trials from activation through close‑out Oversee live protocols, tracking timelines, milestones, and deliverables Ensure compliance with GCP/ICH guidelines, federal regulations, and sponsor requirements Maintain regulatory binders and electronic trial records; ensure inspection readiness Review protocol amendments, study communications, suspensions, and terminations Ensure informed consent documents are current, accurate, and properly filed Perform second‑level patient eligibility review and verify inclusion/exclusion criteria prior to enrollment Attend and support site initiation, monitoring, and close‑out visits Serve as a liaison between investigators, sponsors, CROs, and internal research, regulatory, and data teams Support data quality through review, timely data submission, and collaboration with data coordinators Provide clear updates on enrollment status, patient progress, and trial timelines Coordinate workflow and scheduling with clinic staff across multiple community sites Maintain patient confidentiality and uphold ethical research standards Support vendor coordination and regulatory documentation as needed Required Qualifications Bachelor’s degree At least 1 year of clinical trial experience Experience in operational, regulatory, data‑focused, and sponsor‑facing roles Familiarity with vendor management in clinical research settings Working knowledge of GCP/ICH guidelines and federal regulations Ability to interpret complex clinical trial protocols Proficiency in EDC, EMR, and Microsoft Office Experience supporting multi‑site or community‑based research networks Oncology clinical trial experience preferred Job Type & Location Permanent position based out of Nashville, TN. Pay and Benefits Pay range: $58,000 - $62,000 per year. Benefits include a 401(k) plan, profit sharing, paid time off (PTO), floating holidays, and other standard benefits. Application Deadline Position closes on May 12, 2026. Diversity, Equity & Inclusion Actalent is an equal‑opportunity employer and is committed to diversity and inclusion. #J-18808-Ljbffr Actalent