Sr Clinical Research Coordinator - School of Medicine, Neurology

About VCU

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 employer.

All full‑time university staff are eligible for VCU's robust benefits package that includes comprehensive health benefits, paid annual and holiday leave granted up front, 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.

School of Medicine

Neurology

This position would serve as the Sr. Clinical Research Coordinator for the Center for Inherited Myology Research Program. The program is responsible for developing disease‑modifying and other innovative therapies for individuals with muscular dystrophy. In this role, the incumbent works with a group that leads an international network aimed at achieving this objective.

For all clinical research studies assigned, the Sr. Clinical Research Coordinator is responsible for coordinating clinical research activities in a compliant and efficient manner from study initiation to close‑out. Under the direction of the Principal Investigator (PI), the coordinator collaborates with all members of the clinical research team to ensure all federal, state, university and protocol requirements are followed, institutional research objectives are met, and that ethical obligations are kept.

Core responsibilities are listed below along with other tasks and duties as assigned.

• Independently coordinate study recruitment activities: pre‑screening, screening
• Access allowable data capture/retrieval systems and interact with a variety of health care delivery systems to identify potential study participants
• Conduct and document the initial and ongoing informed consent process for research participants throughout study participation and follow‑up
• Coordinate the enrollment of participants, coordinate and file randomization documents; notifying applicable individuals of registration/randomization (PI, participant, study team, pharmacist, etc.)
• Support the PI and other study staff in following study participants through all study activities to ensure that the study is conducted in compliance with all requirements
• Support the orientation and training of new research team members and other staff
• Work with PI and program staff to ensure all required study close‑out activities are complete
• For assigned studies, coordinate clinical research processes and documentation which may include: filing and office organization, creation of job aids, conducting protocol‑related training, research participant scheduling, ordering of study materials and supplies, and scheduling of meetings

• Understand and adhere to all human subject protection and IRB regulations required for clinical research
• Understand duty to report obligations related to research conduct, and the appropriate university channels for reporting concerns
• Participate in meetings with internal and sponsor‑appointed monitors to ensure accuracy of subject data and compliance with research protocol and regulatory requirements
• Coordinate auditing and monitoring activities for assigned studies

• Assist PI and study team members in the management of study data for new and ongoing clinical research studies assigned
• Maintain study files according to GCP guidelines and in audit‑ready condition
• For assigned studies, ensure subject data is entered into sponsor case report forms, databases and VCU systems in a timely manner and in accordance with sponsor and university
• Review and respond to all queries within required time frames, seeking input from PI’s and other study staff as appropriate