Research Assistant I

FLSA Classification

Non-Exempt

Reports to

Site Director

Works Under the Supervision Of

Clinical Research Coordinator

Summary

Research Assistants (RAs) work under the direction of the Site Director and the supervision of the Clinical Research Coordinator to support the execution of clinical research studies. This is an entry-level position designed to provide hands-on exposure to clinical research operations. Research Assistants assist with study-related tasks including participant coordination, data collection, documentation, and administrative support while ensuring adherence to study protocols, Good Clinical Practice (GCP), and regulatory requirements. The role requires frequent interaction with research participants and clinical staff, strong attention to detail, and the ability to follow established procedures in a regulated environment.

Duties and Responsibilities

• Assist with informing participants about study expectations and visit procedures under supervision
• Prepare and organize study materials such as consent forms, questionnaires, logs, and binders
• Support participant recruitment efforts by identifying and coordinating potential study subjects as directed
• Assist with scheduling study visits and coordinating with clinical and research staff
• Support data collection and documentation in source documents and electronic systems as assigned
• Ensure study documentation is complete, accurate, and filed according to protocol and site requirements
• Observe and support study procedures under appropriate supervision and training
• Promptly report concerns, deviations, or incidents to the Clinical Research Coordinator or Site Director
• Assist with maintaining participant confidentiality and compliance with HIPAA requirements
• Support preparation for monitoring visits, audits, and inspections
• Perform general administrative and operational tasks related to study conduct

Key Competencies

• Strong interpersonal, written, and verbal communication skills
• Ability to follow written protocols, SOPs, and regulatory guidance
• Strong organizational skills and attention to detail
• Ability to work collaboratively with clinical staff, coordinators, and management
• Basic computer proficiency, including Word, Excel, and data entry systems
• Willingness to learn clinical research regulations and procedures

Work Environment

This is a fast-paced clinical research environment that requires flexibility, attention to detail, and professionalism. Variable hours may be required to accommodate study and participant needs. Occasional travel between sites or participation in extended study days may be required.

Physical Demands

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

• Stand and walk for extended periods
• Lift up to 30 pounds occasionally
• Grasp, reach, and handle materials frequently
• Sit with back support for extended periods

Environmental Demands and Potential Hazards

• Exposure to hazards from fluorescent lighting, video screens, computers, copiers, and office equipment
• Work performed within a medical or clinical setting
• Potential exposure to blood, body fluids, infectious diseases, radiation, hazardous chemicals, or medications
• Noise levels range from quiet to moderate
• Periods of sustained focus and moderate stress consistent with clinical operations
• Position may require on-call availability based on study demands and scheduling needs

Required Education and Experience

• High School Diploma or equivalent
• Ability to communicate effectively and professionally with providers, coworkers, participants, and sponsors
• Ability to work in a regulated healthcare or research environment

Preferred Education and Experience

• Associate's degree or coursework in health sciences or related field
• Prior experience in healthcare, research, or customer-facing roles
• Familiarity with medical terminology
• Introductory knowledge of GCP, HIPAA, and clinical research principles

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities required for this position. Duties, responsibilities, and activities may change at any time with or without notice.