Senior Research Associate

The Metis Foundation is seeking a Senior Research Associate to support clinical research within the Military Cardiovascular Outcomes Research (MiCOR) program at the Uniformed Services University of the Health Sciences (USU) in Bethesda, MD. The mission of the MiCOR program is to enhance cardiovascular health and the well-being of service members through innovative clinical research, with research focused on precision medicine, stress, weight gain, genetics, pharmacotherapy, and related domains. 

The Metis Foundation is a 501c (3) specifically organized to advance clinically relevant scientific research in the medical community, especially within the US Department of Defense. The Metis Foundation provides scientific, technical, and programmatic support services to MiCOR and USU.

Responsibilities for this position will include performing clinical research duties within the context of specified research protocols. The position requires an individual who is highly responsible, detail-oriented, and has excellent organizational skills. Prior research experience, especially in the areas of psychology/behavioral medicine, clinical trials, and/or cardiovascular health outcomes is preferred, but not required.

- Recruit and enroll research participants.

- Develop a rapport with research participants and work with staff on explaining protocol and tests/procedures.

- Conduct assessments during participant visits if and when needed.

- Consult with health care professionals regarding medical, psychological, and/or social needs of participants when necessary.

- Track and revise protocol regulatory requirements such as coordinating protocol amendments, writing informed consent forms/HIPAA forms, writing annual reports and Institutional Review Board (IRB) renewals, revising protocol language as needed, and address stipulations issued from the IRB team to reach approval, while keeping investigators apprised of changes.

- Adhere to legal, professional and ethical codes with respect to confidentiality and privacy.

- Coordinate various activities (research subject schedules, data collection, and protocol test procedures) to ensure proper and timely filing of standard clinical/regulatory documentation, serious adverse events, amendments, annual reports and other regulatory documents.

- Visit off-site collaborative centers, as applicable.

- Oversee ongoing protocol operations to ensure study compliance; troubleshoot possible protocol violations.

- Interface with USU or other relevant IRB; coordinate filing of unanticipated events, adverse events, amendments, continuing review applications, annual reports, protocol inactivation, and other regulatory documents.

- Work with staff to develop procedure manuals for clinical research protocols.

- Work with staff to create case report forms and manage research participant files; copy and organize research data.

- Maintain study records, master files, equipment, and supplies.

- Collaborate with PIs to interpret research data.

- Participate in quality improvement and quality assurance initiatives involving database and data system development efforts.

- Work with staff on registering clinical trials on ClinicalTrials.gov, as applicable.

- Participate in efforts to ensure scientific quality and human subjects’ protection.

- Interact with auditing and monitoring agencies to facilitate the exchange of data.

- Interface with other protocol support personnel.

- Perform other duties as needed.

Upon request, the contractor shall provide documentation evidence of any and/or all work product, including, but not limited to, the following tasks:

- Work products and documents related to coordinating research subject schedules, data/biospecimen collection, and participant care; improve processes and services to participants, family members, and colleagues.

- Work products and documents related to recruiting, screening and enrolling subjects; follow subjects between visits; collaborate with co-investigators; serve as a liaison among sites.

- Work products and documents related to the clinical research protocol development, develop procedure manuals; create case report forms; visit off-site collaborative centers; ensure protocol compliance; troubleshoot possible protocol violations.

- Work products and documents related to interfacing with IRB and other regulatory bodies; coordinate filing of documents; conduct staff updates; collaborate with PIs to interpret research data for the protocol team.

Required Knowledge, Skills, and Abilities: Experience in the areas of psychology/behavioral medicine, clinical trials, and/or cardiovascular health is highly preferred, but not required. Knowledge of clinical research data collection and clinical data report preparation, as well as the ability to learn clinical research protocols. Basic understanding of research participant privacy/confidentiality is required. Understanding of clinical research regulatory affairs procedures preferred. Demonstrated expertise in data management. Knowledge of Microsoft Office Suite (Word, Excel, Outlook) and other spreadsheet or database management applications. Strong communication skills, both oral and written. Excellent communication, analytical, organizational, and time management skills. Knowledge of Human Subjects Research and Good Clinical Practice (GCP) is highly recommended.

Minimum Education/Training Requirements: Bachelor's degree (preferred in psychology, nursing, or an allied health field). Master’s degree preferred, but not required.

Minimum Experience: At least 2 years in a clinical research environment.

Physical Capabilities: Periods of sitting, standing, escorting research participants, carrying light items.

Required Licenses, Certification, or Registration: Must be able to obtain applicable Collaborative Institutional Training Initiative (CITI) certifications. Must meet requirements to be able to obtain a DoD Common Access Card. Preferred but not required: CCRA (Certified Clinical Research Associate) credential.

Work Environment: Office and clinical research area; possible evening and/or weekend hours.

Please submit a cover letter and resume/CV. Applications will be reviewed as they are received. If you have any questions about this position, please contact Lisa Shank, PhD, at lisa.shank.ctr@usuhs.edu.