Clinical Research Coordinator

Position Summary

Odyssey is seeking a Clinical Research Coordinator to support the Clinical Investigation Department (CID) at the Navy Medical Center, Portsmouth (NMCP) Virginia. The mission of the command is to support the national interests of the United States by providing professional education and development, providing quality patient care, being responsive and ready for deployment, and taking care of each other as shipmates.

NMCP conducts biomedical research in general surgery, psychology, otolaryngology, pediatrics, nursing research, orthopedics, women’s health, and emergency medicine, which are relevant to the Graduate Medical Education Program.

Duties include, but not limited to:

• Provide research support for IRB and IACUC approved research protocols.
• Support the Department Head of the CID, Directorate for Professional Education, NMCP.
• Support the Department Head of CID and is accountable for research matters to the PIs of each research protocol in accordance with federal and local regulatory guidelines.
• Use programs such as Word, Excel, etc., as well as clinical computer systems including Composite Health Care System (CHCS‑I) and Armed Forces Health Longitudinal Technology Application (AHLTA).
• For consultation, reporting, exchange of information, orientation support for the performance of duties, and to guide patients through a research protocol, will maintain and document contact with study subjects and research personnel from government agencies, granting agencies, industry sponsors.
• Provide IRB/HRPP support to the PI in the development and implementation of recruitment strategies in accordance with IRB/HRPP requirements and approvals.
• Screen recruited research subjects using protocol inclusion/exclusion criteria.
• Refer eligible patients to the PI for final evaluation, enrollment, and randomization per protocol design after the informed consent process has taken place effectively, all subject questions are answered satisfactorily, and the process is documented.
• Assist the research pharmacist with correct receipt, dispensation and accountability/documentation of investigational drugs per the sponsor protocol on Investigational Drug/Device Accountability.
• Provide subjects with education on compliance, possible side effects, drug interactions and the importance of contacting the coordinator and study team members as applicable.
• Assist with maintaining adequate inventory of study supplies, including drugs, and devices, and preparation of other study materials. These study materials include the informed consent document, case report forms (CRFs)/data collection forms (DCFs), enrollment logs, concomitant medication/adverse events logs and drug/device accountability logs.
• Assist the PI by providing materials and tools necessary for the development of appropriate training of individuals involved in the execution of a study related to protocol requirements, schedule of visits, execution of research plan, and maintain documentation of training.
• In collaboration with the PI, check on the performance of phlebotomies, electrocardiograms, vital signs, specimen collection and shipment, and other procedures as required by the protocol.
• Observe universal precautions and OSHA standards when processing or handling specimens.
• Obtain laboratory results and consult with the PI for follow‑up care as per protocol.
• Collect data in a timely and accurate manner and submit information to coordinating centers.
• Report and document adverse events and unanticipated problems to governing agencies and sponsors as required by protocol and regulations.
• Review compliance of research subject and complete documentation of status and progress. Respond to Assurance Specialist discrepancy/findings and, after consultation with PI, communicate approved recommendations.
• Conduct telephone, face‑to‑face interviews or mail information for follow‑up visits as per protocol. Maintain detailed documentation of the research study including subject study charts and databases as required by the protocol, and the Investigator’s File Binder or Regulatory Binder.
• Prepare reports and other correspondence regarding the research protocol for…