Clinical Research Coordinator, School of Medicine, Clinical Research Office

Virginia Commonwealth University (VCU) School of Medicine is a premier academic medical center located in the heart of Richmond. Accounting for almost half of VCU's sponsored research, the School of Medicine is internationally recognized for patient care and education.

Virginia Commonwealth University is an equal opportunity, affirmative action university providing access to education and employment without regard to race, color, religion, national origin, age, sex, political affiliation, veteran status, genetic information, sexual orientation, gender identity, gender expression, or disability.

Position Summary & Core Responsibilities:


The School of Medicine (SOM) Office of Research Administration is seeking candidates with skills in clinical research coordination to join our Clinical Research Office (SOMCRO). The CRC role is part of a team focused on coordination services for SOM investigators. This position provides potential for career growth in the field of clinical research management for those presenting a willingness to learn and ability to work collaboratively with a diverse group of faculty and staff.

Working under the direction of the Senior Program Manager within the Clinical Research Coordinator Pool for SOMCRO, key responsibilities include supporting SOM Investigators in the day-to-day activities required for activation, execution, and management of clinical patient-oriented research studies or protocols. The CRC will be directly responsible for study coordination of clinical research studies covering a variety of diseases and conditions. Additionally, the role includes maintaining current CITI credentials for Human Subjects Protection, Good Clinical Practice (GCP), and other necessary certifications.

Responsibility 1 (50%): Clinical Research Conduct and Coordination

• Manage the day-to-day clinical research activities of assigned studies, including study activation, regulatory compliance, human subject protection, study recruitment, conduct, data management, and study close-out.
• Perform staff in-service/education for ancillary units (e.g., laboratory, radiology, Investigational Drug Service) involved in the study.
• Screen for potential research participants through evaluation of patients using inclusion/exclusion criteria and protocol-specified eligibility requirements.
• Coordinate with physician investigators to explain research studies to potential participants and ensure that informed consent is obtained prior to the initiation of study-related procedures.
• Ensure proper administration/execution of informed consent and ongoing consent of study participants.
• Coordinate with physician investigators to monitor and manage patients' care on research protocols.
• Maintain confidentiality.
• Participate in cross-training and cross-coverage for other members of the pool, ensuring no lapse in administrative aspects of study management or study conduct for studies managed by SOMCRO.
• Cross-coverage across studies and working with the SOMCRO team in true collaboration.
• Complete assigned clinical research activities in a compliant and efficient manner.
• Manage study coordination activities for studies supported by a pool of clinical research coordinators or other study team personnel.

Responsibility 2 (20%): Data Management and Documentation

• Collect, record, and maintain records of all data collected for research participants.
• Ensure safekeeping of records during the study and for the designated period after study closure.
• Ensure timely and accurate data entry into OnCore (clinical trial management system) for both study-level and participant-level data for studies in the portfolio.
• Prepare or assist with required regulatory and IRB ongoing study documentation, including annual progress reports, protocol amendments, and safety reports.
• Enter study data for new and ongoing clinical research studies.
• Assist with the review and response to all sponsor queries as assigned and within required time frames.
• Ensure all documentation is complete.

Responsibility 3 (20%): Regulatory & Compliance Requirements

• Ensure proper research protocol compliance.
• Conduct clinical research activities as authorized by Delegation of Authority and Training Logs.
• Assist in the preparation and collection of all necessary study documentation.
• Participate in SOMCRO internal meetings.
• Ensure accuracy of subject data and compliance with research protocol and regulatory requirements.
• Participate in auditing and monitoring activities as assigned.
• Maintain study files according to GCP guidelines and in audit-ready condition.

Responsibility 4 (10%): Excellence in Customer Service and Team Dynamics

• Provide clear communications to our investigators and study sponsors.
• Understand the importance of ownership of tasks and responsibilities.
• Grow relationships with stakeholders and ensure we deliver on the services provided.
• Develop and nurture relationships with investigators, members of the study teams, departmental personnel, colleagues, and co-workers throughout VCU SOM and VCUHS.
• Communicate with clinical trial sponsors as appropriate (e.g., study activation responsibilities, essential document collection, and ongoing study management and coordination).
• Serve as a liaison between industry sponsors, contract research organizations, faculty investigators, and the institution for promoting the conduct of clinical research at the institution and managing expectations and workflow for specific protocols.

Position will remain open until filled.

The School of Medicine continuously strives for our workplace and learning environment to reflect the demographic and social milieu of the communities we serve. All qualified applicants are encouraged to apply.

VCU is committed to hiring veterans! VCU will include a veteran's period(s) of military service in the calculation of their annual leave accrual rate. This may provide veterans with an increased leave accrual!