Clinical Research Assistant/Lab Technician

JOB SUMMARY: The Metis Foundation is seeking a Clinical Research Assistant to support the Military Cardiovascular Outcomes Research Program (MiCOR) at the Uniformed Services University (USU) in Bethesda, MD. The position would be in support of The COVIVA Study.

The Metis Foundation provides scientific, technical and programmatic support services to MiCOR and USU.

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 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.

Specimen lab processing experience is required. Prior research and/ or medical experience, especially in the areas of cardiovascular health outcomes, is preferred, but not required.

Key Responsibilities:

1. Clinical Trial Management: Assist with various aspects of clinical research projects, including participant recruitment, participant scheduling, study procedures, and data collection.

• - Assist in the recruitment of research participants.
• Collaborate with the research team to schedule necessary participant study visits and procedures.
• Adhere to study SOPs and protocols in order to perform study visits with research participants.
• Work with medical staff on skilled procedures such as vital signs measurement, electrocardiograms, autonomic testing and phlebotomy.
• Process human blood samples in accordance with research protocol and OSHA guidelines.
• Transport human blood and saliva specimens in accordance with the research protocol & IATA guidelines.
• Assist with maintaining research participant files by ensuring that all research documents are appropriately labeled and filed.
• Visit off-site collaborative centers, as applicable.
• Assist with equipment and supply monitoring to ensure that equipment is functioning properly (including temperature monitoring, as applicable) and supplies are stocked and unexpired. Report findings to appropriate research staff.
• Support research staff to develop procedure manuals for clinical research protocols.
• Support research staff to create case report forms.

1. Regulatory Compliance: Adheres to relevant regulations, such as Good Clinical Practice (GCP) guidelines, and assists in maintaining necessary documentation for audits.

• Adheres to legal, professional and ethical codes with respect to confidentiality and privacy.
• Assist with production, tracking, and revision of advertising materials for IRB approval.
• Ensure compliance of environmental health regulations in the lab.

1. Participant Interaction: Effectively interact with study participants, ensuring that the research project is being conducted according to GCP standards.

• Assist the research team with developing participant rapport and effectively explaining the protocol and study procedures.

1. Data Management: Collect, record, and assist with managing data, maintaining the confidentiality and accuracy of research records.

• Document clinical encounters via established guidelines.
• Accurately document and record experimental procedures, observations, and outcomes. Use critical thinking to generate complete documentation.
• Participate in quality improvement and quality assurance initiatives involving database and data system development efforts.
• Interact with auditing and monitoring agencies to facilitate the exchange of data.
• Provide support for analyzing and interpreting laboratory data, as applicable, ensuring accuracy and reliability in results.

1. Laboratory processing: Support and perform laboratory testing on human biological specimens. Analytical chemistry, immunology and molecular biology assays may be conducted.
2. - 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.

• Performs immunological assays on human peripheral blood samples, including preparation for flow cytometry, in vitro culture, supernatant collection, and cytokine quantification by ELISA or Luminex-based assays.
• Conduct complex laboratory tests and experiments, following established protocols and procedures.
• Operate and maintain sophisticated laboratory equipment, troubleshooting issues as needed.
• Prepare and standardize reagents and solutions for experiments.
• Assist in the development and optimization of laboratory methods and procedures.
• Maintain the cleanliness of the laboratory and organization of laboratory freezers and refrigerators.
• Assist in ordering laboratory supplies, maintaining order log, maintaining chemical inventory.
• Maintain detailed laboratory notes for specific research projects.
• Stay updated on relevant scientific literature and technological advancements in the field.

1. Collaboration: Collaborate with cross-functional teams, including physicians, research scientists, and data analysts, to achieve research goals and meet participant medical, psychological and/or social needs.

• Interface with other protocol support personnel as needed.
• Collaborate with team members to plan and execute experiments safely, efficiently and in accordance with all applicable regulations.

This is not an exhaustive list and the CRA will be expected to perform other duties as needed.

Required Knowledge, Skills, and Abilities:

Demonstrated expertise in data management.

Experience working with human samples and lab processing procedures. Knowledge of Microsoft Office Suite (MS Word, Excel, Outlook) and other spreadsheet applications. Strong communications skills, both oral and written.Ability to learn clinical research protocols and meet deadlines of projects.

Minimum Education/Training Requirements: Bachelor’s degree (preferred in Biology or related field).

Minimum Experience: at least 1 year in a clinical research or patient care environment preferred. At least 1 year in laboratory processing is required.

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 research assistant duties required and may be obtained upon hire. Must also be able to obtain a government issued common access card.

Work Environment: Office, laboratory, 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.