Clinical Research Coordinator

Overview

Goldbelt Apex, a part of the Healthcare Technology Transformation Group, is a data-focused company dedicated to process and quality in every aspect. As healthcare IT experts, Apex is committed to building systems for healthcare organizations to seamlessly communicate and exchange data across different systems and devices.

Clinical Research Coordinator (CRC) to provide specialized scientific and clinical research support to the Defense Health Agency (DHA) Clinical Investigation Program at Naval Medical Center Portsmouth (NMCP). The CRC will independently coordinate assigned clinical and biomedical research activities supporting the Clinical Investigation Department (CID), Combat Trauma Research Group (CTRG), Graduate Medical Education (GME) Program, and other NMCP clinical departments. The position requires advanced knowledge in biological sciences, health sciences, physiology, or a closely related scientific discipline, acquired through specialized academic education and applied to the coordination, evaluation, and execution of complex research protocols.

The CRC will exercise independent professional judgment in assessing research activities, evaluating scientific and regulatory information, identifying protocol compliance risks, resolving research coordination issues, and recommending scientifically appropriate corrective actions. The CRC will collaborate with Government Principal Investigators (PIs), research scientists, medical personnel, and institutional research oversight bodies to support the successful execution of Institutional Review Board (IRB) and Institutional Animal Care and Use Committee (IACUC)-approved research.

• Essential Job Functions:
  • Independently coordinate assigned clinical and biomedical research activities, applying specialized scientific knowledge to the execution and management of approved research protocols.
  • Evaluate research requirements, protocol objectives, study methodologies, and operational constraints to determine appropriate coordination strategies within approved protocols.
  • Exercise independent professional judgment in identifying scientific, procedural, or operational issues that may affect study quality, regulatory compliance, participant safety, or research timelines.
  • Analyze research documentation, study progress, and collected information to identify discrepancies, emerging issues, and opportunities for improvement.
  • Evaluate complex research coordination challenges and recommend appropriate solutions to the PI and other authorized research personnel.
  • Independently prioritize assigned research activities, coordinate resources, and adjust operational schedules to meet established research milestones.
  • Apply advanced knowledge of biological and health sciences when interpreting study requirements and coordinating research activities involving human and animal research protocols.
• Clinical Research Protocol Execution
  • Coordinate the implementation and execution of assigned IRB/IACUC-approved clinical research protocols, exempt research, non-human-subject research, and quality improvement/quality assurance projects.
  • Independently assess study coordination requirements and develop operational plans that support the PI's approved research objectives.
  • Evaluate study eligibility criteria and assist with participant recruitment and screening, referring eligibility determinations requiring medical or PI judgment to authorized personnel.
  • Coordinate patient scheduling, clinical evaluations, laboratory testing, specimen collection, and other protocol-required research activities.
  • Support the informed consent process and verify that consent documentation has been completed in accordance with approved protocols and applicable requirements.
  • Coordinate research procedures, including phlebotomy, electrocardiograms, intravenous infusions, vital signs, and specimen collection, as authorized by the applicable protocol and the individual's professional qualifications.
  • Evaluate operational barriers affecting protocol execution and independently develop recommendations for resolution within established research and regulatory requirements.
• Regulatory Compliance and Research Quality
  • Apply professional knowledge of IRB/IACUC requirements, Good Clinical Practice (GCP), applicable Federal regulations, and institutional research procedures to assigned research activities.
  • Independently review research records and study activities to identify potential protocol deviations, incomplete…