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 crossdepartmental 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 fastpacedenvironment while helping to support the success of the VCU School of Medicines 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 proactive and work collaboratively.

Typical Duties

Study Conduct (50%)

• Assist in subject recruitment: prescreening 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 closeout 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 VCUs 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%)

• Crosscoverage 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.

Minimum Qualifications

• Bachelors Degree or equivalent related experience
• Must be able to prioritize work requirements and multitask in fastpaced environment seeking guidance from Principal Investigators and senior study team staff when necessary.
• Ability to be flexible with working hours and shift requirements.
• Exhibits professionalism and ability to work both independently and collaboratively as part of a team.
• Establish and maintain productive relationships with VCU colleagues and all customers and contacts necessary to effectively support research studies.
• Must be dependable and attentive to detail.
• Must be able to prioritize work requirements and multitask in fastpaced environment seeking guidance from Principal Investigators and senior study team staff when necessary.
• Ability to read interpret and apply complex regulations policies and requirements studies.
• Excellent organization time management and critical thinking skills.
• Accuracy precision and efficiency in work habits are required.
• Must be able to use time effectively multitask and work independently.
• Demonstrated experience working in and fostering an environment of respect professionalism and civility with a population of faculty staff and students from various backgrounds and experiences or a commitment to do so as a staff member at VCU.

Preferred Qualifications

• Masters Degree or equivalent experience in the sciences preferred.
• Healthcare experience preferred.
• Familiarity with RedCap Microsoft Programs EPIC and/or OnCore a plus.
• Familiarity with VCU Health preferred.
• Active clinical licensure such as CMA CAN EMT RN LPN preferred.
• Prior experience working in clinical research is preferred.
• Multilingual skills preferred.

Kelly Barnes

Required Experience:

IC