Clinical Trial Assistant

Clinical Trial Assistant

This is an exciting opportunity to join a growing company that .focuses on precise, early detection of emerging diseases. The Clinical Trial Assistant (CTA) will support the planning, execution, and documentation of clinical studies in compliance with applicable regulations and internal procedures. Ideal candidates will be highly motivated and detail-oriented with 3 years of experience in biotech or in vitro diagnostics.

Responsibilities:

• Support study start-up, maintenance, and close-out activities across multiple clinical trials.
• Partner with CROs, clinical sites, and vendors to drive on-time achievement of critical study milestones.
• Oversee clinical supply chain management, including inventory tracking, shipment coordination, and site correspondence.
• Develop and review essential study documentation, including protocols, informed consent forms, case report forms, and monitoring plans.
• Facilitate data collection processes and drive timely resolution of data queries.
• Contribute to internal and external meetings by documenting key decisions, action items, and ensuring timely follow-through.
• Prepare regulatory submissions, ethics committee applications, and study start-up packages to support trial initiation.

Requirements and Desired Experience:

• Bachelor’s degree in life sciences, healthcare or similar field.
• 3–5 years of experience as a CTA in healthcare, biotech, diagnostics, or medical device industry.
• Working knowledge of IVD clinical trial design and applicable regulatory requirements, including IVDR, ISO 14155, and Good Clinical Practice guidelines.
• Proficiency with Trial Master File systems and clinical trial management platforms for documentation and study tracking.
• Comprehensive understanding of clinical trial processes, documentation standards, and operational workflows.
• Experience supporting Class C IVD studies under IVDR is a plus
• Knowledge of clinical utility and performance evaluation studies is a plus
• Prior involvement in post-market surveillance activities is a plus
• Able to work independently and collaboratively
• Detail-oriented with a proactive approach to problem-solving
• Strong organizational and communication skills.
• Proficient Excel, Word and PowerPoint skills.

Compensation (DOE): $25 - $32 per hour