Clinical Trial Assistant

• Assist Clinical Research Associates and Regulatory and Start-Up teams with updating and maintaining clinical documents and systems, including the Trial Master File
• Prepare, handle, distribute, file, and archive clinical documentation and reports according to the scope of work and standard operating procedures
• Review study files periodically for completeness
• Assist with preparation, handling, distribution, and tracking of Clinical Trial Supplies
• Track and manage Case Report Forms, queries, and clinical data flow
• Act as a central contact for designated project communications, correspondence, and associated documentation
• May accompany Clinical Research Associates on site visits to assist with clinical monitoring duties after required training

• Assist with the coordination and administration of clinical trials
• Report to the Manager of Site Operations and the Principal Investigator or designee
• Support achievement of patient enrollment goals and contribute to enrollment strategies
• Assist with patient identification and recruitment
• Provide customer service to patients, participants, healthcare partners, investigators, sponsors, and vendors
• Build relationships with local patient populations and internal and external partners
• Ensure scientific integrity and accurate recording of source data, patient visit data, CTMS records, electronic reports, and sponsor case report forms
• Resolve queries in a timely manner
• Keep study documentation current and audit ready
• Assist with conducting and documenting informed consent
• Coordinate and schedule patient visits and conduct visits according to protocols
• Assist with clinical and laboratory procedures, including vital signs, EKGs, and collecting, processing, and shipping bodily samples
• Follow SOPs, GCPs, protocols, OSHA requirements, PPE procedures, and other regulatory requirements
• Maintain continuous learning and development related to clinical trial operations and patient experience
• Foster teamwork and collaboration with healthcare system representatives
• Perform additional assigned tasks

Clinical Trial Assistant jobs in United States

Clinical Trial Assistant

Assistant Clinical Trial Navigator – Temporary