Adverse Events, Behavioral Health, Case Report Form (CRF), Clinical Research, Clinical Support, Clinical Trial, Data Collection, Data Quality, Documentation, GCP (Good Clinical Practices), IRB/IEC (Institutional Review Board/Independent Ethics Committee), Informed Consent, Leadership, Maintain Compliance, Medical Records, Medical Research, Medicine, Military, Nonprofit, Organizational Skills, Patient Assessment, Post Traumatic Stress Disorder (PTSD), Project Tracking, Regulations, Regulatory Compliance, Regulatory Requirements, Regulatory Submissions, Research Protocols, Safety Compliance, Specimen Collection, Startup
- Reviews new patient records and screens participants for eligibility in research protocols.
- Interviews patients for study participation and collects appropriate data to support recruitment activities, including assessing patient commitment and obtaining informed consent.
- Educates patients about the research protocol, their role in the study, and all required procedures, risks, and expectations.
- Collects, organizes, catalogs, disseminates, and maintains accurate and complete research data and study files.
- Serves as a liaison between patients, study therapists, investigators, and physicians, acting as a key patient resource throughout the study.
- Enters, transcribes, and resolves data queries in case report forms (paper and/or electronic systems) in collaboration with study leadership.
- Ensures strict adherence to legal, professional, and ethical standards related to confidentiality, participant safety, and data integrity.
- Assures all protocol activities comply with Good Clinical Practice (GCP), institutional policies, and regulatory requirements.
- Schedules participant visits, study sessions, and follow‑up appointments, coordinating closely with clinical and research staff.
- Assists with monitoring visits, audits, and inspections by sponsors, IRBs, and regulatory authorities.
- Supports regulatory activities, including maintenance of regulatory binders, protocol amendments, adverse event documentation, and IRB submissions, as assigned.
- Monitors participant safety, including documenting and reporting adverse events and protocol deviations in accordance with study and regulatory requirements.
- Coordinates with therapy teams and study leadership to ensure protocol‑driven timing, data collection, and session requirements are met, particularly in support of MDMA‑assisted therapy sessions.
- Assists with and/or manages elements of study project tracking and clinical operations including, but not limited to regulatory submissions, training logs, study personnel records, and additional as needed.
- May perform other duties as assigned, including required training and ongoing education relevant to the role.
Join the HJF Team!
HJF is seeking a Clinical Research Coordinator II that will play a key role in executing a first-of-its-kind clinical trial at Walter Reed National Military Medical Center (WRNMMC). This position will be critical in ensuring compliance, safety, and efficiency at all stages of the study lifecycle, including but not limited to study startup, participant recruitment efforts, data and specimen collection, project tracking, and study operations.
This position will be in support of the WRNMMC Directorate of Behavioral Health, Advanced Therapeutics Program. This Clinical Research Coordinator II role will support a clinical trial of MDMA-Assisted Therapy (MDMA-AT) for service members with PTSD, and potentially similar clinical trials in the future.
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