Clinical Research Manager

Company DescriptionGastroenterology Consultants of Southwest Virginia is a busy, fast-growing GI practice conducting cutting-edge clinical research in partnership with national sponsors and CROs. We are seeking an experienced Clinical Research Supervisor to support and lead our expanding research department. This role is ideal for someone who loves both hands-on clinical research and team leadership.Role DescriptionThe Clinical Research Supervisor oversees the daily operations of our research department while also performing some direct clinical research duties. This role ensures studies are conducted in accordance with GCP, FDA regulations, IRB requirements, and practice protocols. The ideal candidate is organized, detail-oriented, and comfortable balancing leadership responsibilities with coordinator-level tasks.Key ResponsibilitiesSupervisory Responsibilities• Oversee day-to-day operations of the clinical research department.• Train, mentor, and evaluate research staff; assign study workloads and support ongoing development.• Monitor study quality, regulatory compliance, and documentation accuracy.• Prepare for and manage sponsor/CRO monitoring visits, audits, and inspections.• Review Regulatory Binders and Subject Binders for accuracy and compliance.• Maintain and enforce Standard Operating Procedures (SOPs).• Support the Principal Investigator with protocol oversight and departmental goals.Clinical Research Coordinator Duties• Conduct patient visits and follow clinical trial protocols.• Obtain informed consent for applicable studies.• Pre-screen patients using EMR and inclusion/exclusion criteria.• Perform phlebotomy, lab specimen processing, shipping, and IP accountability.• Enter data into EDC systems; randomize subjects; resolve queries.• Maintain ISF, regulatory documents, subject binders, and temperature logs.• Coordinate scheduling with vendors and ensure SOE compliance.• Submit IRB applications (initial, continuing review, amendments, close-out).• Collect and document AEs/SAEs and notify PI appropriately.• Assist with budgeting, invoicing, and study financial tracking.• Serve as liaison between patients, investigators, sponsors, CROs, and vendors.Qualifications• Bachelor’s degree in health sciences, life sciences, or related field (preferred) • Previous experience as a Clinical Research Coordinator for a minimum of two years (required).• Strong working knowledge of GCP, FDA regulations, IRB requirements, and HIPAA/OSHA.• Phlebotomy skills or willingness to learn within 90 days.• High attention to detail and strong organizational skills.• Excellent communication, teamwork, and leadership abilities.• Proficient in Microsoft Office, Excel and EMR systems.• Research certification (SoCRA/ACRP) preferred or willingness to obtain.Benefits • Competitive compensation based on experience.• Monday–Friday schedule, no nights or weekends.• Health, dental, vision, HSA, life insurance, and 401(k).• Supportive physician team and strong administrative leadership.• Opportunity to advance as the research department continues to grow.• Relocation assistance provided