Clinical Trial Assistant

Position Overview

The Clinical Trial Assistant (CTA) plays a vital role by providing essential operational and administrative assistance throughout the phases of clinical trials. Reporting directly to the Clinical Trial Manager or Clinical Operations Lead, the CTA ensures that trial documentation is meticulously maintained and supports coordination of study activities with internal and external stakeholders. This role demands adherence to Good Clinical Practice (ICH-GCP), company SOPs, regulatory guidelines, and trial protocols.

Key Responsibilities

• Deliver daily operational support for Phase I-IV clinical studies and assist with trial startup, conduct, maintenance, and closeout procedures.
• Monitor study milestones, timelines, and actionable tasks to facilitate smooth trial progression.
• Organize logistics for investigator meetings and study team discussions, including documentation such as minutes.
• Manage and maintain the electronic Trial Master File (eTMF) to ensure completeness, accuracy, and audit readiness.
• Review trial documents for quality and filing accuracy; track and follow up on missing documents with internal staff, CROs, and study sites.
• Support vendor and Contract Research Organization (CRO) communications, track deliverables, assist in resolving issues, and handle document exchanges.
• Assist site activation efforts, including collecting essential documents and coordinating shipment of study materials and regulatory packets.
• Respond to routine inquiries from study sites and assist with site payments and supply coordination as needed.
• Support the preparation and upkeep of essential regulatory documents to ensure compliance with ICH-GCP, company SOPs, and regulatory standards.
• Maintain clinical systems such as CTMS, eTMF, EDC, and document management platforms, including generating reports and managing document versions.
• Collaborate across multiple departments including Clinical Operations, Regulatory Affairs, Data Management, Clinical Supply, Medical Writing, Pharmacovigilance, Quality Assurance, and Finance.
• Assist with administrative tasks such as coordinating travel and meetings, preparing agendas, tracking study documentation, and managing vendor payment processes.

Qualifications

• Bachelor's degree in Life Sciences, Health Sciences, Nursing, Public Health, or a related discipline preferred; equivalent combinations of education and clinical research experience are also considered.
• 1 to 3 years’ experience in supporting clinical trials within biotech, pharmaceutical, CRO, or academic research environments.
• Prior roles as a Clinical Trial Assistant, Clinical Research Coordinator, or comparable positions are preferred.
• Experience with outsourced clinical trials is desirable.