Clinical Research Coordinator - II

JOB SUMMARY

The Metis Foundation is seeking a Clinical Research Coordinator II to support the Military Cardiovascular Outcomes Research Program (MiCOR) at the Uniformed Services University (USU) in Bethesda, MD. This position will provide on‑site support to MiCOR projects such as the Genetic Exploration of Military Sudden Cardiac Arrest (GEMini) protocol, located at the Naval Medical Center (NMCSD) in San Diego, CA. The Metis Foundation is a 501(c)(3) specifically organized to advance clinically relevant scientific research to the medical community, especially within the U.S. Department of Defense. We provide scientific, educational, financial, and project management support in the conduct of federally and industry‑sponsored research, clinical trials, and education. The Metis Foundation provides scientific, technical, and programmatic support services to MiCOR and USU. MiCOR is a program intended to understand the impact of military service—particularly precision medicine, stress, weight‑gain, exercise, and pharmacotherapy—on cardiovascular risk. The mission of the MiCOR Program is to enhance the cardiovascular health and well‑being of the Warfighter and the DOD community through innovative clinical research using precision techniques. MiCOR has a variety of clinical research studies focused on both the biomedical and behavioral components that contribute to cardiovascular risk and disease. This position will have duties at the Naval Medical Center San Diego. The candidate may also be required to obtain a Secret Clearance and undergo credentialing prior to beginning work. The CRC II will be responsible for providing support at NMCSD located in San Diego, CA. The Clinical Research Coordinator II (CRCII) will assist the Genetic Exploration of Military Sudden Cardiac Arrest (GEMini) protocol. GEMini is an observational, non‑randomized study of the genetic contributions to Sudden Cardiac Arrest in the Military and their families. The CRC II will play a pivotal role in planning, coordinating, and executing clinical research studies. This position requires an experienced and dedicated individual who can ensure smooth conduct of clinical trials, maintain compliance with regulatory requirements, and support the research team in achieving project objectives. A minimum of 2 years of prior research and/or medical experience is required. Previous experience in cardiovascular health outcomes is preferred, but not required. Key Responsibilities Coordinate and oversee all aspects of clinical research projects, including participant recruitment, informed consent, study procedures, and data collection. Coordinate informed consent process according to GCP and MiCOR SOP guidelines. Coordinate various clinical activities (research participant schedules, data collection, and protocol test procedures). Adhere to study SOPs and protocols to perform study visits with research participants. Oversee the development and implementation of study recruitment plans. Work with medical staff on skilled procedures such as vital signs measurement, electrocardiograms, autonomic testing and phlebotomy. Oversee processing of human blood samples in accordance with research protocol and OSHA guidelines. Oversee transport of human blood and saliva specimens in accordance with research protocol and IATA guidelines. Oversee staff development of procedure manuals and case report forms for clinical research protocols. Visit off‑site collaborative centers, as applicable. Ensure strict adherence to relevant regulations, such as GCP guidelines, and maintain necessary documentation for audits. Adhere to legal, professional, and ethical codes with respect to confidentiality and privacy. Oversee ongoing protocol operations to ensure study compliance and troubleshoot possible protocol violations. Interface with Uniformed Services University or other relevant IRB to assist with coordination of revisions to the protocol, regulatory requirements such as protocol amendments, reportable events, HIPAA forms, annual reports and IRB renewals. Ensure proper and timely filing of standard clinical/regulatory documentation. Develop participant rapport, starting with the informed consent process, ensuring participants understand protocol and study procedures. Document data via established guidelines. Participate in quality improvement and quality assurance initiatives involving database and data system development efforts. Interact with auditing and monitoring agencies to facilitate data exchange. Interface with other protocol support personnel. Work with investigators and medical writers on the production/revision of clinical research protocols. Ensure that all required training is completed and documented according to protocol and GCP. Maintain protocol training files for all study team members. Promote a culture of mutual care and respect, striving to make the most meaningful and positive impact. Additional duties may be assigned as needed. Required Knowledge, Skills, and Abilities Preferred: Experience in cardiovascular clinical research; understanding of clinical research regulatory affairs procedures. Required: Basic patient care principles and patient privacy/confidentiality. Knowledge of clinical research data collection and clinical data report preparation; demonstrated expertise in data management. Excellent analytical, organizational, and time‑management skills. Knowledge of Human Subjects Research and GCP. Knowledge of Microsoft Office Suite (Word, Excel, Outlook) and other spreadsheet applications. Strong communication skills, both oral and written. Ability to learn clinical research protocols and meet project deadlines. Minimum Education/Training Requirements Bachelor’s degree (preferred in biology or allied health). Minimum Experience At least 2 years in a clinical research or patient‑care environment preferred; educational equivalent may be considered. Experience in cardiovascular or neuroscience clinical research is highly preferred. Physical Capabilities Long periods of sitting, standing, escorting participants, carrying light items; may encounter participants who are confused, agitated, or abusive. Required Licenses, Certification or Registration CPR/BLS Certification and CITI certification in GCP and Clinical Research Coordinator duties required and may be obtained upon hire. Must also be able to obtain a government‑issued common access card. Work Environment Office and clinical patient care area; possible evening and/or weekend hours. Metis Foundation is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of Human Resources. Pay $60,000.00 – $70,000.00 per year Benefits 401(k) 401(k) matching Dental insurance Employee assistance program Flexible spending account Health insurance Health savings account Life insurance Paid time off Retirement plan Tuition reimbursement Vision insurance Education Bachelor's (Required) Experience Clinical research: 2 years (Preferred) Work Location In person #J-18808-Ljbffr The Voluntary Protection Programs Participants' Association, Inc