Clinical Research Coordinator | School of Medicine | Neurosurgery

Summary:

The VCU School of Medicine (SOM) is seeking candidates with an interest in clinical research to join the cross-departmental School of Medicine research group, the Clinical Trial Collaborative (CTC). This is a salaried, benefited position that will provide an opportunity to contribute to learn about clinical research coordination and operations in a fast-paced, environment while helping to support the success of the VCU School of Medicine’s research enterprise.

Existing clinical trials supported by the CTC study best practices or novel interventions after neurological injury, cardiac arrest, and other acute, critical care, and emergent conditions. CTC staff work across floors of the hospital and communicate with all services from Emergency Medical Services (EMS), through intensive care, surgical services, and into patient rehabilitation.

SOM is committed to supporting VCU clinical researchers in advancing medical science in our region. The Clinical Research Coordinator is a key part of a team focused on implementing coordination services for SOM investigators with the goal of providing 24/7/365 enrollment support for Acute Care Clinical Trials. The selected candidate(s) will be responsible for conducting Clinical Research across the SOM under the direction of the Senior Clinical Research Coordination Staff and the Department of Neurosurgery. This position will require day/evening/night coverage on a shared, rotating schedule. Team members are designated to work during “off hours” to obtain the goal of providing 24/7/365 study enrollment coverage among a collaborative of research professionals. The work schedule will include weekends (Saturday and/or Sunday) or holidays, as needed. The position will also present opportunities for career growth for those presenting a willingness and ability to learn, be pro-active, and work collaboratively.

Typical Duties

Study Conduct (50%)

• Assist in subject recruitment: pre-screening and screening.
• Enrollment of eligible study participants.
• Conduct the informed consent process.
• Monitor patients within VCU Health during participation and throughout the study follow up period.
• Access data capture/retrieval systems to identify potential study participants.
• Supervise per diem CRCs and assist with scheduling duties.
• Maintenance of study documents.
• As assigned, support the PI and other senior study staff in following study participants through all study activities to ensure that the study is conducted in compliance with all requirements.
• Assist with required study close-out activities.

Data Management & Documentation (25%)

• Entry of study data for new and ongoing clinical research studies.
• Maintain study files according to GCP guidelines and in audit ready condition.
• Enter subject data into sponsor case report forms, databases, and VCU’s OnCore system in a timely manner and in accordance with sponsor and university/school -level requirements.
• Assist with the review and response to all sponsor query replies as assigned and within required time frames.

Regulatory & Compliance Requirements (15%)

• 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.
• Maintain appropriate study documentation/records.
• Maintain current CITI credentials for Human Subjects Protections, Good Clinical Practice (GCP), Clinical Research Coordinator, plus additional sponsor GCP certifications as required.
• Understand and adhere to all IRB requirements, Human Subjects protection regulations, and all aspects of IRB approved protocols.
• Conduct all assigned activities in compliance with national, local, & institutional guidelines, according to all HIPAA, GCP, and other applicable requirements.
• Preparation of IRB submissions including initial submissions, continuing reviews, amendments, safety reports, and serious adverse event reporting.
• Participate in SOMCRO and SOMCTC internal meetings.
• Ensure accuracy of subject data and compliance with research protocol and regulatory requirements.
• Participate in auditing and monitoring activities as assigned.

General/Administrative (10%)

• Cross-coverage across studies and working with the SOMCRO team in true collaboration.
• Completing assigned clinical research activities in a compliant and efficient manner.
• Coordination of clinical research processes and documentation which may include filing and office organization, research participant scheduling, and ordering of study materials and supplies.
• Follow all university and School of Medicine procedures for management of clinical research.