Adverse Events, Clinical Best Practices, Clinical Nursing, Clinical Practices/Protocols, Clinical Research, Clinical Trial, Cross-Functional, Data Collection, Data Entry, Data Quality, Documentation, Employee Orientation, GCP (Good Clinical Practices), Informed Consent, Investigational New Drug (IND), Maintain Compliance, Medical Research, Medical Treatment, Medicine, Mentoring, Military, Nonprofit, Organizational Skills, Pediatrics, People Management, Phlebotomy, Policy Implementation, Quality Assurance, Regulations, Regulatory Compliance, Regulatory Requirements, Regulatory Submissions, Research Protocols, Research Skills, Specimen Collection, Staff Training, Standard Operating Procedures (SOP), Vaccination
- Leads the coordination and execution of clinical research protocols, ensuring studies are conducted efficiently, safely, and in full compliance with regulatory and institutional requirements.
- Provides feedback to the Principal Investigator to monitor the overall conduct of clinical trials, to include subject care and other issues that may affect subject safety, protocol adherence, and/or program operations.
- Maintains responsibility for regulatory compliance across the study lifecycle, including preparation and oversight of eIRB submissions, protocol amendments, and essential regulatory documentation.
- Leads preparation for monitoring visits, audits, and inspections, ensuring readiness and adherence to human subjects protection standards.
- Conducts and oversees participant recruitment, subject screening, eligibility assessment, and the informed consent process, ensuring adherence to protocol requirements and regulatory standards.
- Accountable for enrollment goals, protocol compliance, quality assurance, adverse event monitoring and reporting, accurate data entry in data collection systems, and overall participant experience.
- Rare after-hours phone availability may be required to serve as a point of contact for emergency participant needs and to coordinate with the Principal Investigator and other study team members regarding serious adverse event (SAE) assessment and reporting, or any other urgent participant-related matters.
- Serves as the clinical and operational lead for assigned studies, leveraging clinical research expertise to guide and oversee protocol-specific clinical procedures, including participant assessments, specimen collection (e.g., pediatric blood draws), and administration of study interventions such as vaccines.
- Performs clinical procedures as needed while ensuring study staff are appropriately trained, competent, and adhering to protocol requirements and clinical research standards.
- Trains, mentors, and supervises research staff on protocol requirements, clinical procedures, and best practices, promoting a high-performing, compliant, and participant-centered research environment.
- Collaborate with the Principal Investigator to draft, edit, and develop sections of research protocols, research proposals, and unit standard operating procedures (SOPs) to support study implementation and regulatory compliance.
- May support multiple protocols and perform other duties as assigned.
Join the HJF Team!
HJF is seeking a Clinical Research Coordinator III to lead the operational and clinical execution of pediatric research protocols in support of the Uniformed Services University Department of Pediatrics in Bethesda, MD.
This role integrates comprehensive research study coordination with advanced clinical expertise, ensuring compliant study management and high-quality participant engagement. The incumbent will develop and oversee the operational conduct of clinical research studies in accordance with Good Clinical Practice GCP, ensuring meticulous attention to protocol adherence, data integrity, and participant safety with high fidelity. Leveraging their clinical nursing expertise, the Clinical Research Coordinator III will perform and support study-related clinical procedures, including pediatric blood draws and the administration of investigational products. The individual will also provide hands-on training, oversight, and guidance to study staff to ensure the accurate and compliant execution of clinical procedures within the research setting. Working closely with the Physician Principal Investigator, the Clinical Research Coordinator III will manage the full clinical research lifecycle, including regulatory submissions, eIRB processes, and adherence to human subjects protections, ensuring studies are conducted with rigor, strong organization, and the highest ethical standards within a multidisciplinary team while keeping the study actively progressing and on track.
The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine. We serve military, medical, academic and government clients by administering, managing and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike. Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners. HJF's support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and accomplish their research goals.
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The Henry M Jackson Foundation for the Advancement of Military Medicine Inc