Clinical Research Assistant

Description

The Clinical Research Assistant is an entry-level clinical research professional who works closely with Clinical Research Coordinators, the Clinical Research Director, and Principal Investigators to support the day-to-day conduct of clinical trials.

At Clinical Trials Center of Middle Tennessee, Research Assistants are active members of the study team and are expected to progressively develop knowledge of clinical research regulations, study protocols, patient visit activities, research documentation, data entry, and overall study management.

As training and competency are demonstrated, the Clinical Research Assistant may assume increasing responsibility for study activities under the supervision of experienced research staff and in accordance with the study delegation of authority. Above all, every member of the research team is responsible for protecting the rights, safety, and well-being of patients participating in clinical research.

• Work closely with Principal Investigators, Clinical Research Coordinators, and the Clinical Research Director to support the daily conduct of assigned clinical trials.
• Develop a working knowledge of assigned study protocols, including study objectives, visit schedules, inclusion and exclusion criteria, required procedures, and study timelines.
• Review and become familiar with Investigator's Brochures, laboratory manuals, pharmacy manuals, study reference materials, and other protocol-specific guidance as applicable.
• Assist with identifying and prescreening potential research participants using protocol-specific eligibility criteria.
• Assist with scheduling participant visits, testing, procedures, and study-related follow-up.
• Support study visits and perform protocol-required activities for which the Research Assistant has been appropriately trained and delegated.
• Interact professionally and compassionately with research participants and provide clear study-related instructions within the scope of the Research Assistant's role.
• Support the informed consent process and, when appropriately trained and delegated, participate in or conduct informed consent discussions in accordance with the protocol, IRB requirements, site procedures, and applicable regulations.
• Assist with implementation of revised or amended informed consent forms and confirm appropriate documentation of the consent process.
• Track participant enrollment and study status, including screening outcomes, missed visits, withdrawals, and participant contact attempts.
• Assist with timely processing of participant stipends or reimbursements when applicable.

• Prepare, complete, and maintain accurate study documentation in accordance with the protocol, Good Clinical Practice (GCP), sponsor requirements, and site SOPs.
• Assist with the development, organization, and maintenance of protocol-specific source documentation.
• Complete study source documentation accurately and contemporaneously for delegated study activities.
• Enter clinical trial data into electronic data capture (EDC), eSource, sponsor, and other study-specific systems as assigned.
• Assist with maintaining Case Report Forms (CRFs) and responding to data clarification requests or queries under coordinator supervision.
• Maintain participant study records, study logs, visit documentation, and other essential study documents.
• Assist with maintaining paper and electronic study files in an organized, inspection-ready manner.
• Assist with investigational product or device accountability documentation when appropriately trained and delegated.
• Maintain study supply inventories and notify the appropriate team member when supplies, laboratory kits, or study materials require replenishment.

• Conduct all assigned research activities in accordance with the study protocol, Good Clinical Practice, applicable federal regulations, IRB requirements, sponsor requirements, and Clinical Trials Center of Middle Tennessee policies and procedures.
• Recognize potential adverse events, protocol deviations, or other study concerns and promptly communicate them to the Clinical Research Coordinator and Investigator.
• Assist with documentation of adverse events and other safety information as directed by the Investigator or Clinical Research Coordinator.
• Maintain participant confidentiality and comply with HIPAA and other applicable privacy requirements.
• Identify questions, inconsistencies, or potential protocol…