Clinical Research Coordinator

Job Overview

MPF Federal seeks a Clinical Research Coordinator I to support the Naval Health Research Center (NHRC), Operational Infectious Diseases (OID) Directorate by coordinating and managing clinical research studies. The OID Directorate conducts ongoing, laboratory-based surveillance of U.S. military populations in unique environments to quantify and study the etiology of infectious illnesses. Test specimens are collected from ongoing surveillance programs and from special investigations of febrile illnesses and pneumonia among military personnel or civilians.

Portable, rapid assay technologies are used to identify pathogens in the field, and specimens are sent to the NHRC laboratory for diagnostics and pathogen characterization. Results are provided to sponsors, the Armed Forces Health Surveillance Center, local investigators, collaborators, and county health units to guide responses that ultimately affect both military readiness and public health safety.

• Patient Recruitment and Consent:
  Identify, recruit, and obtain informed consent from potential study participants in compliance with study protocols and ethical guidelines.
• Lead recruitment efforts, developing and refining strategies to meet enrollment targets.
• Make independent decisions about participant eligibility and target selection.
• Manage complex clinical trials, handling logistics, compliance issues, and protocol adjustments as needed.
• Study Protocol Design and Oversight:
  Interpret protocols, assess feasibility, and modify procedures to align with clinical trial objectives.
• Study Visits:
  Coordinate and conduct patient interviews, sample collection, and other protocol-driven procedures.
• Data Collection and Entry:
  Accurately collect, record, and manage study data; ensure timely entry into the Clinical Trial Management System (CTMS).
• Data Analysis and Reporting:
  Interpret data to recommend research direction and adjust study parameters based on preliminary findings.
• Query Resolution:
  Work with the study team to resolve data queries and discrepancies in accordance with Good Clinical Practice (GCP) guidelines.
• Compliance and Regulatory Decisions:
  Interpret and apply regulatory requirements, ensuring trials comply with legal, ethical, and institutional standards.

• Assist with Institutional Review Board (IRB) submissions and protocol amendments.
• Collaborate with principal investigators and sponsors, providing insights based on field experience.
• Recommend changes to improve study feasibility and evaluate implications of protocol adjustments.
• Ensure compliance with all regulatory requirements, including study registrations in the electronic IRB (eIRB) system.

• Maintain accurate study documentation and ensure protocols are adhered to throughout the study lifecycle.
• Ensure the research team follows procedures; troubleshoot and resolve deviations or challenges.
• Develop and implement quality control procedures, identify improvement areas, and resolve issues impacting study validity.
• Prepare for and participate in monitoring visits, audits, and inspections by regulatory agencies.

• Prepare and submit initial and continuing IRB applications, study amendments, and adverse event reports in compliance with NHRC and sponsor requirements.
• Ensure all study-related documents are appropriately filed and accessible for audits.
• Manage study registrations and updates in the CTMS and eIRB system.

• May provide oversight and guidance to Assistant Clinical Research Coordinators and other support personnel.
• Conduct research activities in varied environments, such as on naval ships or remote sites, which may involve travel.
• Coordinate logistics, including equipment and resource allocation, and serve as a research team representative on-site.
• Make real‑time decisions regarding study operations and troubleshoot unexpected scenarios to ensure study fidelity and safety.

• A BA/BS in biological sciences, public health, or equivalent OR 5+ years of clinical research experience.
• Familiarity with regulatory requirements for clinical trials, including IRB submissions and…