Clinical Trials Associate

Role: Clinical Operations Associate supporting trial planning, start-up, maintenance, and closeout activities within a biotech setting. Responsibilities: develop study documents (protocols, ICFs, IBs), liaise with investigators and site staff to foster sponsor-site relationships, review regulatory packets, monitor data quality, manage biological sample logistics, support meeting coordination, track IMP supplies, and oversee TMF submissions with CROs. Also assists with study finance, vendor invoicing, and process improvements. Requirements: BA/BS with at least 2 years of experience in clinical research at investigator sites, CROs, or sponsors; strong knowledge of ICH/GCP and FDA regulations; effective communication and organizational skills; experience with eTMFs preferred. High-Value: clinical trial support, regulatory compliance, sample management, TMF oversight, cross-functional collaboration, biotech environment, protocol development, and trial logistics.