Clinical Research Coordinator 1

Clinical Research Coordinator I

MPF Federal seeks a Clinical Research Coordinator I to support the Naval Health Research Center (NHRC).

Compensation: $68,000-$73,000 annually

Primary Responsibilities

• Patient Recruitment and Consent: Identifies, and obtains informed consent from potential study participants in compliance with study protocols and ethical guidelines.
• Help lead recruitment efforts, developing and refining strategies to meet enrollment targets.
• Make independent decisions about how to target and select participants, and whether a potential participant meets eligibility criteria.
• Manage and coordinate complex biosurveillance.
• Study Protocol Design and Oversight: Interprets study protocols, assessing feasibility, and modifying procedures to align with the objectives of clinical trials.
• Study Visits: Coordinates and conducts study visits, including patient interviews, sample collection, and other protocol-driven procedures.
• Data Collection and Entry: Accurately collects, records, and manages study data. Ensures timely data entry into the Clinical Trial Management System (CTMS).
• Data Analysis and Reporting: Interprets data to make recommendations on the direction of the research and adjusts study parameters based on preliminary findings.
• Query Resolution: Works with the study team to resolve data queries and discrepancies in accordance with Good Clinical Practice (GCP) guidelines.
• Compliance and Regulatory Decisions: Interprets and applies regulatory requirements, ensuring trials comply with legal, ethical, and institutional standards, and addressing issues without minimal supervision by the Clinical Program Manager.

Regulatory Management

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

Compliance and Monitoring

• Maintains accurate study documentation and ensures that study protocols are adhered to throughout the study lifecycle.
• Ensure that the research team follows procedures. Troubleshoot and resolve any deviations or challenges that may arise.
• Develop and implement quality control procedures, identify areas for improvement, and resolve any issues that could impact the validity or integrity of the study outcomes.
• Prepares for and participates in monitoring visits, audits, and inspections by regulatory agencies.

Regulatory Responsibilities

• Prepares and submits initial and continuing IRB applications, study amendments, and adverse event reports in compliance with NHRC and sponsor requirements.
• Ensures all study-related documents are appropriately filed and accessible for audits.
• Manages study registrations and updates in the Clinical Trial Management System and eIRB system.

Other Responsibilities

• May be required to provide oversight and guidance to Assistant Clinical Research Coordinators and other support personnel.
• Remote and On-Site Study Leadership:
• Conduct research activities in varied environments, such as on naval ships or other 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.
• Performs other duties as assigned.