Clinical Trial Assistant, Clinical Operations

About The Opportunity

Our client is seeking a detail-oriented and proactive Clinical Trial Assistant (CTA) to join their team for a 6–12+ month engagement. This high-priority role supports the day-to-day execution of Phase I-III clinical trials. As a critical operational partner to the clinical operations team, you will ensure study documentation remains audit-ready and that study milestones are tracked effectively. This role offers broad exposure to clinical trial execution in a fast-paced, high-impact environment.

Key Responsibilities & Deliverables

This role is focused on the successful coordination of clinical study activities. Your responsibilities will include:

• Operational Support: Provide daily support to Clinical Trial Managers and the broader Clinical Operations team.
• Documentation & TMF Management: Maintain essential study documentation, ensure Trial Master Files (TMF) are complete and inspection-ready, and manage the quality control of clinical trial documents.
• Study Coordination: Support study startup, site activation, and ongoing maintenance activities.
• Meeting Management: Coordinate meetings with internal teams, CROs, vendors, and study sites; prepare agendas, document minutes, and track follow-up action items.
• Vendor & Site Communication: Assist with investigator site communications and support vendor management activities and deliverables tracking.
• Data & Compliance: Perform data entry, tracking, and reporting within clinical systems; support audit and inspection readiness activities.
• Process Improvement: Contribute to departmental projects and process improvement initiatives as needed.

Required Skills & Experience

We are looking for a highly organized professional to support our study teams. The ideal candidate will have:

• 2–5 years of experience in Clinical Trial Assistant, Clinical Research Coordinator, or Clinical Operations roles.
• Demonstrated experience supporting Phase I-III clinical studies.
• Working knowledge of FDA regulations, ICH-GCP guidelines, and clinical trial processes.
• Strong hands-on experience with eTMF systems (proficiency in CTMS, EDC, and other clinical systems is a plus).
• Bachelor’s degree in Life Sciences, Healthcare, Nursing, Biology, or a related discipline.
• Strong attention to detail with the ability to manage multiple priorities in a fast-paced environment.
• Excellent communication, organizational, and follow-through skills.

Additional Information

W2 only (No C2C or 1099 contractors)