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 US 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 (recruits, forces afloat, deployed forces, outbreaks of concern, and border populations). In addition to the utilization of portable, rapid assay technologies to identify pathogens in the field, test specimens and limited epidemiologic data, when approved by the Institutional Review Board (IRB), are provided to the NHRC laboratory where diagnostics and, in some instances, in-depth pathogen characterization is conducted. Results are provided to sponsors, the Armed Forces Health Surveillance Center, local investigators and collaborators, and, when applicable, county health units to guide proper responses that ultimately affect both the readiness of US forces and the safety of public health.
Responsibilities
Primary Responsibilities
· Patient Recruitment and Consent: Identifies, recruits, 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 clinical trials: Handle complex logistics of trials, solve problems related to compliance or participant concerns, and make adjustments to protocols based on emerging situations during the study.
· Study Protocol Design and Oversight: Interprets study protocols, assesses feasibility, and modifies 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.
Required Qualifications:
· A BA/BS in biological sciences, public health, or equivalent OR 5 plus years of clinical research experience.
· Familiarity with regulatory requirements for clinical trials, including IRB submissions and reporting processes.
· Willingness to obtain a phlebotomy certificate in accordance with the other duties.
· Proficiency in Clinical Trial Management Systems (CTMS) and electronic IRB systems.
· Strong organizational, communication, and problem-solving skills.
· Ability to work both independently and collaboratively in a research setting.
· US Citizenship and the ability to obtain and maintain a T3/Secret Clearance.
· Ability to wear a N95 mask (or similar) if/when required.
Preferred:
· Certification in clinical research (such as CCRC or CCRP).
· Experience with infectious disease studies or military health research.
Some positions or sites may require that the incumbent be fully vaccinated against COVID-19, and proof of vaccination may be required.
MPF Federal is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status or on the basis of disability. We offer a competitive compensation package including a competitive salary, medical benefits, PTO, holiday pay and more.
