Job DescriptionHJF 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.
Responsibilities- 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.
QualificationsEducation and Experience- Bachelor's degree required.
- Minimum of 6-8 years of clinical research experience required.
Required Knowledge, Skills and Abilities- Experience supporting clinical research with human participants is required.
- Prior experience with phlebotomy and certification required. Pediatric phlebotomy preferred.
- Must have prior experience working with children or pediatric patients.
- Exceptional attention to detail in reviewing and preparing clinical research documents, including protocols, regulatory submissions, consent forms, and study-related materials, ensuring accuracy, consistency, and compliance with institutional, regulatory, and Good Clinical Practice (GCP) standards.
- Strong knowledge of federal, state, and institutional regulations governing human subjects research.
- Advanced clinical skills with the ability to oversee and guide protocol-specific participant care.
- Experience with pediatric clinical care, demonstrating proficiency in vital sign acquisition, blood draws, vaccine administration, and other procedural skills.
- Demonstrated leadership, delegation, and team management abilities.
- Excellent organizational, analytical, and problem-solving skills with the ability to manage multiple priorities.
- Strong interpersonal and communication skills, with the ability to lead multidisciplinary teams and engage participants and families effectively.
- Excellent computer skills, including experience with MS Office and Google products (MS Outlook, MS Excel, MS Word, MS PowerPoint, Google Drive, Google documents) and Adobe Professional.
- Ability to obtain and maintain a T1 Public Trust background check.
Physical Capabilities- Ability to stand or sit for prolonged periods and perform clinical tasks as needed.
- May require lifting up to 25 lbs.
- Ability to perform clinical procedures and operate standard medical and office equipment.
- Ability to travel across NSA Bethesda campus, including walking or driving distances of up to 0.5 mile between work locations.
- Ability to operate motor vehicles, machinery, and/or power tools.
Licenses and Certifications - Certification in Basic Life Support (BLS) is required.
- Certification in Advance Pediatric Life Support highly preferred.
- Certification as a Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) is highly preferred.
Work Environment- This position is primarily based in an office and clinical research setting with direct participant interaction, with occasional travel to support research activities at additional sites.
Compensation- The annual salary range for this position is $67,500 - $100,000. Actual salary will be determined based on experience, education, etc.
Benefits- HJF offers a comprehensive suite of benefits focused on your health and well-being, from medical, dental, and vision coverage to health savings and retirement plans, and more.
Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, education and credentials, a criminal background check, and a department of motor vehicle (DMV) check if applicable. Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.
Direct Link: Clinical Research Coordinator III (Phlebotomy) - Pediatrics - HJF Career Site Careers
