Clinical Research Assistant - Metis Foundation

JOB SUMMARY: 

The Metis Foundation is seeking a Clinical Research Assistant to support a protocol in collaboration with two research programs at the Uniformed Services University of the Health (USU) Sciences in Bethesda, MD: the Military
Cardiovascular Outcomes Research program (MiCOR) and the Translational Medicine Unit (TMU).

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. MiCOR is working in
collaboration with the TMU for this exciting study.

The TMU was founded in the late 1980’s as the Clinical Pharmacology Unit by Dr. Louis Cantilena, MD, PhD. It is a storied unit with major contributions to medical product development and scientific literature. TMU currently conducts more than adozen clinical research studies and aims to conduct 2-4 clinical trials a year of novel products to benefit military medicine and to protect and treat warfighters engaged in Multi-Domain Operating environments. This position will potentially have duties at Walter Reed National Military Medical Center and the candidate may be required to obtain a Secret Clearance as well as undergo Credentialing before beginning work.

Clinical Research Assistant (CRA) will be responsible for assisting the COVIVA project which is a Comparative cohort study of post-acute COVID-19 infection with a nested, randomized control trial of Ivabradine for those with postural orthostatic
tachycardia syndrome. Participants will be followed for one year in both the cohort and the RCT portion of the study. Responsibilities for the CRA include performing clinical research and participant care in conjunction with a specified clinical research protocol. The position requires an individual who is highly responsible and who has excellent communication and organizational skills. Prior research and/ or medical experience, especially in the areas of cardiovascular health outcomes, is preferred, but not required.

The Metis Foundation is a 501c (3) specifically organized to advance clinically relevant scientific research to the medical community, especially within the US 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, TMU and USU.

ESSENTIAL JOB DUTIES:

• Adheres to legal, professional and ethical codes with respect to confidentiality and privacy.
• Collaborate in the recruitment of research participants. Screen and enroll research participants.
• Develop participant rapport and work with staff on explaining protocol and tests/procedures.
• Adhere to study SOPs and protocols in order to perform study visits with research participants.
• Consult with health care professionals regarding medical, psychological and/or social patient needs.
• Document via established guidelines.
• Produce, track, and revise advertising materials for IRB approval.
• Develops study recruiting plans in concert with the study team to include use of social media and other platforms.
• Coordinate various activities (research participant schedules, data collection, and protocol test procedures) to ensure proper and timely filing of standard clinical/regulatory documentation.
• Process human blood samples, including isolation and purification of peripheral blood mononuclear cells (PBMCs), cryopreservation of PBMCs, serum and plasma, and purification of DNA and RNA.
• Transport human blood and saliva specimens as needed.
• Work with medical staff on skilled procedures such as autonomic testing and phlebotomy.
• Work with staff to develop procedure manuals for clinical research protocols.
• Work with staff to create case report forms.
• Visit off-site collaborative centers, as applicable.
• Oversee ongoing protocol operations to ensure study compliance; troubleshoot possible protocol violations.
• Interface with Uniformed Services University or other relevant Institutional Review Board (IRB); coordinate filing of unanticipated events, adverse events, amendments, continuing review applications, annual reports, protocol inactivation and other regulatory documents.
• Manage research participant files; copy and organize research data.
• Maintain study records, master files, equipment, and supplies.
• Support the needs of data integrity and retrieval.
• Participate in quality improvement and quality assurance initiatives involving database and data system development efforts.
• 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.
• Performs other duties as needed.

DELIVERABLES:
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 providing clinical care for outpatient clinical programs; document patient care via established guidelines.
• Work products and documents related to coordinating research participant schedules, data/bio specimen collection and participant care; work with medical staff on skilled procedures; order protocol-mandated tests, labs and procedures; improve processes and services to participants, family members and colleagues.
• Work products and documents related to recruiting, screening and enrolling participants; follow participants between visits; collaborate with community physicians; serve as liaison among sites (if applicable).
• Work products and documents related to 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 protocol team.

Required Knowledge, Skills, and Abilities: 

Experience in Cardiovascular clinical research is highly preferred. Knowledge of clinical research data collection and
clinical data report preparation. Basic patient care principles and patient privacy/confidentiality are required. Understanding of clinical research regulatory affairs procedures preferred. Demonstrated expertise in data management.
Knowledge of Microsoft Office Suite (MS Word, Excel, Outlook) and other spreadsheet applications. Strong communications skills, both oral and written. Excellent analytical, organizational and time management skills. Knowledge of Human Subjects Research and Good Clinical Practice (GCP) is highly recommended; ability to learn clinical research protocols, meet deadlines of projects.

Minimum Education/Training Requirements: Bachelor’s degree in Biology or related field preferred. Phlebotomy skills and experience are highly desirable.

Minimum Experience: at least 1 year in a clinical research environment 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 Certified preferred and able to obtain CITI certification in GCP and research assistant duties.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 the Director of Human Resources.