Clinical Research Assistant

University Physicians' Association, Inc. is seeking a qualified full-time Clinical Research Assistant candidate for Edmunds Gastroenterology, a fast-paced GI practice in Knoxville, TN. 

Job Summary

The Clinical Research Assistant supports the planning, coordination, and execution of clinical research studies in compliance with regulatory requirements, study protocols, and institutional policies. This role assists investigators and clinical research staff with participant recruitment, data collection, documentation, and study-related administrative tasks to ensure high-quality and ethical research conduct.

Key Responsibilities:

• Assist with the day-to-day operations of clinical research studies and trials
• Support participant recruitment, screening, enrollment, and follow-up activities
• Collect, record, and maintain accurate study data in case report forms (CRFs), electronic data capture systems, and source documents
• Prepare and maintain regulatory binders and study documentation in accordance with IRB, GCP, and sponsor requirements
• Coordinate study visits, schedules, and communications with participants and study staff
• Assist with informed consent processes under the supervision of authorized personnel
• Perform basic clinical tasks as permitted (e.g., vital signs, specimen handling, questionnaire administration)
• Able to do lab draws on patients
• Support monitoring visits, audits, and inspections
• Ensure confidentiality and proper handling of protected health information (PHI)
• Communicate effectively with investigators, coordinators, sponsors, and regulatory bodies
• Assist with inventory management of study supplies and investigational products (as applicable)

Required:

• Strong attention to detail and organizational skills
• Ability to follow protocols, standard operating procedures, and regulatory guidelines
• Proficiency with Microsoft Office and basic data management tools
• Excellent written and verbal communication skills

Preferred:

• Prior experience in clinical research, healthcare, or laboratory settings
• Familiarity with Good Clinical Practice (GCP) and IRB processes

Skills and Competencies:

• Strong time management and multitasking abilities
• Professional and ethical conduct
• Ability to work independently and as part of a multidisciplinary team
• Problem-solving and critical-thinking skills
• Comfort interacting with patients and research participants

Work Environment:

• Clinical, hospital, academic, or research office setting
• May involve direct patient interaction
• Possible early mornings, occasional evenings, or weekend hours depending on study requirements

Physical Requirements:

• Ability to sit, stand, and walk for extended periods
• Ability to lift and move light research materials and supplies