Hourly Clinical Research Coordinator - School of Medicine, Neurosurgery

Core Responsibilities

• 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. Coordinate and file study documents. As assigned, support the PI and other senior study staff in following study participants through all study activities to ensure 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. Prepare IRB submissions including initial submissions, continuing reviews, amendments, safety reports, and serious adverse event reporting. Participate in SOM, CTC, and study specific 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 CTC 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.

Required Qualifications

• Must be able to prioritize work requirements and multi-task in fast-paced 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 multi-task in fast-paced 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, multi-task, and work independently.
• Demonstrated ability to work in and foster 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

• Bachelor’s 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.
• Prior experience working in clinical research is preferred.
• Multilingual skills preferred.