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.
  • Monitoring 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.
  • Preparation of 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.
  • Coordinate 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.

• Must be able to prioritize work requirements and multi‑task in a 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 work in a diverse environment and encourage inclusion.
• Ability to read, interpret, and apply complex regulations, policies, and requirements of 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.

• Bachelor's Degree or equivalent experience in the sciences preferred.
• Healthcare experience preferred.
• Familiarity with Red Cap, Microsoft Programs, EPIC and/or OnCore a plus.
• Familiarity with VCU Health preferred.
• Active clinical licensure such as CMA, CAN, EMT, RN, LPN.
• Prior…