Clinical Trial Associate

Clinical Trial Associate

The Clinical Trial Associate (CTA) serves as a central point of contact for the study team, supporting the planning, execution, and close-out of both outsourced (CRO-managed) and in-house clinical studies. This role works independently on day-to-day study documentation, tracking, and coordination activities, while exercising sound judgment on when to escalate or loop in other functional areas (e.g., Regulatory Affairs, Clinical Operations, Data Management). Key Responsibilities TMF/eTMF Management Own the setup, maintenance, quality control (QC), and close-out of the Trial Master File (TMF)/electronic Trial Master File (eTMF). Track and maintain study essential documents, including CVs, Form FDA 1572s, lab certifications, IRB/IEC approvals, and site/vendor contracts. Ensure TMF completeness, accuracy, and inspection readiness throughout the study lifecycle. Study Coordination & Metrics Maintain and update study metrics, including monitoring visit reports, regulatory document trackers, and contact/vendor lists. Prepare agendas and minutes for study team meetings. Support the planning and execution of investigator meetings and monitor workshops (logistics, materials, follow-up items). Regulatory & Data Support Coordinate with Regulatory Affairs on document turnover, submission timelines, and deadline tracking. Assist with data reconciliation and clinical data review activities in support of study team quality checks. Maintain and update public clinical trial registries (e.g., ClinicalTrials.gov, EudraCT/CTIS) to ensure accuracy and compliance with disclosure requirements. Cross-Functional Support Act as a liaison between the study team, CROs, vendors, and internal functions to ensure smooth study execution. Identify potential issues or delays in documentation/regulatory processes and escalate appropriately. Support general study start-up, conduct, and close-out activities as needed. Requirements Required Qualifications 2+ years of experience in biotech, pharma, or clinical trial support (sponsor or CRO). Bachelor's degree in a scientific discipline (e.g., life sciences, biology, chemistry, or related field). Working knowledge of TMF/eTMF structure and essential document requirements (per ICH-GCP). Strong organizational skills and high attention to detail. Ability to manage multiple priorities and deadlines independently. Strong written and verbal communication skills. Willingness and ability to travel approximately 30%. Preferred Qualifications Experience with eTMF systems (e.g., Veeva Vault, Master Control, or similar). Familiarity with clinical trial registry requirements (ClinicalTrials.gov, EudraCT/CTIS). Experience supporting investigator meetings or monitor training/workshops. Exposure to data reconciliation or clinical data review processes.