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.

ResponsibilitiesStudy and Patient Support

• 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.

Clinical Research Documentation and Data

• 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.

Safety and Protocol Compliance

• 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 issues and escalate them appropriately rather than making independent clinical determinations outside the scope of the role.

Study Operations

• Assist with study start-up activities and preparation of study-specific materials, logs, source documents, training materials, and tracking tools.
• Assist with maintenance of regulatory and study documentation as assigned.
• Participate in study-specific training and maintain required training documentation.
• Assist the research team with implementation of IRB-approved recruitment and patient identification strategies.
• Maintain effective communication with investigators, coordinators, research participants, sponsor and CRO representatives, and other study personnel.
• Assist with preparation for sponsor monitoring visits, site initiation visits, close-out visits, audits, and regulatory inspections.
• Participate in monitoring visits and assist with addressing monitor requests and outstanding action items.
• Assist with resolution of study documentation or data issues identified through internal review, monitoring, or quality assurance activities.
• Attend investigator meetings, study training meetings, and other research-related meetings as requested.
• Perform additional research-related duties and study activities as assigned and appropriate to training, competency, and delegation.

Professional Development

The Clinical Research Assistant position is intended to provide hands-on experience across the clinical research process. Research Assistants will receive training in clinical research operations and will be expected to progressively develop the skills necessary to manage increasingly complex study responsibilities. Successful Research Assistants may be considered for advancement into a Clinical Research Coordinator position based on demonstrated competency, performance, professional development, and organizational needs.

Requirements:

• Bachelor’s degree preferred in biology, health sciences, psychology, public health, nursing, or a related field; associate degree with relevant healthcare, research, or patient-facing experience may be considered. 
• Prior clinical research experience is not required; training will be provided. 
• Strong interest in developing a career in clinical research and progressing toward a Clinical Research Coordinator role. 
• Strong attention to detail and ability to follow protocol-driven processes. 
• Comfortable working directly with patients and within a fast-paced clinical environment. 
• Strong written and verbal communication skills. 
• Ability to manage multiple priorities and maintain accurate, timely documentation. 
• Proficiency with standard computer systems; ability to learn clinical research platforms such as eSource, EDC, and sponsor systems. 
• Dependability and professional judgment—particularly important because research documentation and patient visits are time-sensitive.