Clinical Research Assistant - Department of Epidemiology

Unit: School of Public Health MBU Department: Epidemiology Position Summary: The Clinical Research Assistant (CRA) will support the coordination and conduct of biomedical behavioral clinical trials under the direction of the Principal Investigators and Lead Clinical Research Coordinator.

Responsibilities include

participant recruitment, screening, enrollment, informed consent, data collection, study procedures, quality assurance, and maintenance of study documentation and data. The CRA will assist with tracking and reporting adverse events and protocol deviations, study activation, regulatory and compliance activities, and adherence to IRB-approved protocols, HIPAA, Good Clinical Practice (GCP), and applicable federal, state, local, and institutional requirements.

The CRA must maintain required CITI, Human Subjects Protection, GCP, and Clinical Research Coordinator certifications, as well as any sponsor-required training. The position requires strong interpersonal and communication skills, cultural competence, and the ability to collaborate effectively with investigators, research staff, interdisciplinary teams, and participants from a variety of backgrounds and lived experiences.

Core Responsibilities Study Recruitment and Participant Management: Supports the implementation of research protocols by recruiting, screening, interviewing, and enrolling participants through telephone, electronic, and/or in-person interactions. Screens potential participants for study eligibility in accordance with approved study protocols and monitors screening, enrollment, and ineligibility rates.

Conducts orientation and informed consent visits and obtains and documents written informed consent in accordance with IRB-approved procedures. Clearly explains study purpose, procedures, benefits, risks, and participant responsibilities to potential participants and their support systems, as applicable. Distributes IRB-approved recruitment materials and assists with community engagement and research promotion, including social media outreach when applicable.

Identifies and troubleshoots recruitment and retention challenges in a research-compliant manner. Implements strategies to retain participants and supports completion of required follow-up visits and study activities. Assists with participant compensation and maintains accurate compensation and participation records. Maintains participant and study records as required by the VCU IRB and applicable study protocols.

Works independently while collaborating effectively with Principal Investigators (PIs), the Lead Clinical Research Coordinator (CRC), research staff, and other study personnel. Participant Data Collection and Management: Conducts and supports study assessments, including collection of anthropometric, physical, interview, survey, and other protocol-required data.

Performs electronic medical record screening and data abstraction, as applicable. Coordinates and/or oversees collection of biological specimens, such as blood and saliva, in accordance with approved study procedures and within applicable training and competency requirements. Collects, records, and enters study data accurately and independently, as well as in collaboration with other research staff.

Completes data entry using approved electronic data capture and research platforms. Maintains study tracking databases to monitor recruitment, participant progress, study visits, and overall study activities. Performs data quality control procedures and identifies and addresses data discrepancies in accordance with study protocols.

Maintains accurate, complete, and timely research records and documentation. Ensures laboratory equipment and spaces are sanitized and reset after participant visits. Clinical Trial and Research Administration: Supports, facilitates, and carries out qualitative and/or quantitative human subjects research projects, including single- and multi-site studies, as applicable.

Works closely with the Lead CRC and PIs to coordinate day-to-day study operations and ensure research activities are conducted in accordance with approved protocols. Assists with regulatory and compliance activities, including preparation and maintenance of IRB documentation, continuing review materials, data and safety monitoring reports, and other required regulatory submissions.

Maintains study regulatory files, trial binders, and other essential study documentation. Assists with the development, revision, and maintenance of study Manuals of Procedures, standard operating procedures, policies, and other study-related materials. Regularly reviews and audits research records for compliance with VCU, VCU Health System, departmental, IRB, federal, state, and local requirements, as applicable.

Upholds human subjects protection requirements, ethical research practices, and duty-to-report obligations related to research conduct. Assists with the preparation and maintenance of study materials, including intervention materials, recruitment flyers, advertisements, and participant-facing documents. Coordinates with PIs and the Lead CRC to maintain study supplies and inventory and assist with participant reimbursement.

Assists with organizing study meetings and preparing and disseminating meeting minutes, reports, and other study communications, as applicable. Assists with the coordination and oversight of research assistants, interns, and other study personnel as assigned. Clinical Skills, Biosafety, and Training: Completes required VCU and VCU Health System orientation, training, and competency requirements for clinical research activities.

Performs approved clinical research activities within the scope of training, education, licensure, and study-specific requirements. Completes required competency verification before performing clinical activities in VCU Health System clinical areas. Delivers study interventions to participants Maintains all required VCU and VCU Health System competencies related to clinical research activities, biosafety, and human subjects research.

Follows all applicable biosafety, infection control, occupational health, and research safety requirements. Does not perform clinical activities requiring a professional license unless the required license is current, documented, and approved by VCU and/or VCU Health System. Other Duties and Team Support: Performs other related duties and responsibilities as assigned.

Attends team meetings and trainings as directed, providing status updates as requested. Supports the overall goals and operations of the research team and contributes to a collaborative, respectful, and participant-centered research environment. Maintains effective communication and collaboration with PIs, Lead CRCs, research coordinators, research assistants, research administrators, and other faculty and staff.

Flexibility to work varied hours, including early mornings for research assessments and occasional evenings and weekends, as needed. Willing to travel to deliver or pick up study equipment from participants within the Metro Richmond Area.

Qualifications

Minimum Qualifications

Bachelor’s degree or equivalent in health sciences or a related field. Familiarity with the research process, principles of research design, and basic research procedures. Demonstrated knowledge of HIPAA regulations, medical terminology, and confidentiality requirements. Proficiency with computer applications, including word processing, spreadsheets, databases, and virtual meeting platforms such as Zoom and Microsoft Teams; entry-level data entry skills required.

Experience demonstrating strong interpersonal, written, and verbal communication skills, with the ability to establish rapport and respond empathetically to research participants. Demonstrated experience using critical thinking, problem-solving, and sound judgment skills, with the ability to independently respond to challenges.

Demonstrated exceptional organizational and time management skills, with the ability to multitask, prioritize responsibilities, and maintain attention to detail in a fast-paced research environment. Demonstrated experience working effectively both independently and as part of an interdisciplinary team. Participant- and quality-oriented, with a commitment to consistently centering participants’ needs, experiences, and confidentiality.

Preferred Qualifications

Master’s degree in health sciences, epidemiology, public health, psychology, or a related field. Previous experience as a research assistant or in a research coordinator role, particularly within behavioral or clinical trials. Experience recruiting, screening, consenting, and/or conducting study procedures with research participants.

Experience working with electronic data capture and research management systems, including REDCap, as well as Electronic Medical Records (EMR). Familiarity with federal, institutional, and other regulations, policies, and procedures governing clinical research and study conduct. Experience with phlebotomy or willingness to receive training in phlebotomy.

Experience in teaching or coaching or willingness to receive training in delivery of psychoeducational content or heart rate variability biofeedback. Demonstrated knowledge, skills, and abilities relevant to the responsibilities of the position, with the ability to apply them effectively in a clinical research environment.

Position will remain open until filled. Applications received by November 12, 2026 will be given priority consideration. Salary Range: $45,000 - $50,000 Benefits : All full-time university staff are eligible for VCU’s robust benefits package that includes comprehensive health benefits, paid annual and holiday leave, generous tuition benefits, retirement planning and savings options, tax-deferred annuity and cash match programs, employee discounts, well-being resources, abundant opportunities for career development and advancement, and more.

FLSA Exemption Status: Non-Exempt Hours per Week: 40 Restricted Position: Yes ORP Eligible: No Flexible Work Arrangement: Fully Onsite University Job Title: Clinical Research Assistant I-III Contact Information: Contact Name: Cian Brooks Contact Email: [email protected]