Position Title: Clinical Research Coordinator, Full-Time (3 Positions)
Contract Duration: 12-month base period with renewable option periods
Location: Bethesda, Maryland
Department: Veritas Management Group/NIH SOAR
Veritas Management Group (VMG) is a leading management consulting firm offering solutions to complex challenges involving public health, technology, and military domains. We serve government and commercial sector organizations, academic institutions, and non-profit organizations, domestically and globally. We are committed to transforming public health through equitable, data-driven solutions.
VMG is seeking three (3) Clinical Research Coordinators to support the National Cancer Institute (NCI), Office of the Clinical Director (OCD). This position provides comprehensive clinical research coordination for oncology and cancer-related clinical trials conducted within the NCI Intramural Research Program. The Clinical Research Coordinator will support all phases of clinical research, including participant recruitment, protocol implementation, regulatory compliance, data management, specimen coordination, and study closeout while ensuring adherence to federal regulations and Good Clinical Practice (GCP) standards.
- Coordinate oncology clinical trials from study start-up through study closeout.
- Screen, recruit, enroll, and schedule research participants according to protocol requirements.
- Assess participant eligibility using approved inclusion and exclusion criteria.
- Support informed consent activities in collaboration with the Principal Investigator and clinical team.
- Coordinate protocol-required clinic visits, laboratory testing, imaging studies, diagnostic procedures, and ancillary services.
- Serve as the primary point of contact for study participants, caregivers, investigators, and clinical staff.
- Collect, review, validate, and enter clinical research data into electronic data capture systems.
- Maintain accurate source documentation, case report forms (CRFs), regulatory binders, and study files.
- Monitor data quality, resolve data queries, and prepare enrollment, accrual, and study status reports.
- Coordinate collection, processing, storage, tracking, and shipment of research specimens.
- Obtain and review outside medical records, pathology reports, laboratory results, and diagnostic imaging required for study participation.
- Assist with preparation and submission of regulatory documentation, including Institutional Review Board (IRB) submissions, protocol amendments, continuing reviews, and study closures.
- Support monitoring visits, audits, inspections, and quality assurance activities.
- Track protocol deviations, adverse events, regulatory deadlines, and required study documentation.
- Collaborate with investigators, research nurses, data managers, and multidisciplinary clinical teams to ensure participant safety and protocol compliance.
- Assist with training and mentoring new research coordinators and study personnel on protocol procedures and Good Clinical Practice (GCP).
- Bachelor's degree in Nursing, Biological Sciences, Public Health, Health Sciences, Clinical Research, or a related field.
- Experience supporting oncology clinical trials or clinical research operations.
- Knowledge of FDA regulations, International Council for Harmonisation Good Clinical Practice (ICH-GCP), human subjects protections, and clinical trial methodology.
- Experience using electronic medical records (EMR), clinical trial management systems (CTMS), and electronic data capture (EDC) platforms.
- Strong organizational, project coordination, analytical, and communication skills.
- Demonstrated experience supporting clinical trials from start-up through closeout.
- Proficiency with Microsoft Office Suite, including Word, Excel, and PowerPoint.
- Experience supporting NIH, NCI, or other federally funded oncology clinical research programs.
- Experience coordinating Phase I, II, or III oncology clinical trials.
- Experience with specimen management, pharmacokinetic (PK), pharmacodynamic (PD), biomarker, and imaging studies.
- Experience preparing regulatory submissions and supporting monitoring visits and audits.
- Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP), or equivalent certification.
- Experience mentoring clinical research staff and coordinating multidisciplinary clinical research teams.
- Full-time position (40 hours per week).
- Monday through Friday schedule.
- Position is located at the National Cancer Institute, Office of the Clinical Director, Bethesda, Maryland.
- Telework is available in accordance with government approval.
- Professional clinical research environment supporting oncology clinical trials and cancer research.
- Frequent collaboration with physicians, nurses, research participants, regulatory personnel, laboratory staff, and multidisciplinary research teams to support high-quality clinical research operations.
