Clinical Research Monitoring (CRA)

The primary responsibility of this individual is to review and inspect US and international clinical research and clinical trial sites engaged by USAMRIID, Division of Medicine. The secondary responsibility of this individual will be to assist with clinical research efforts at USAMRIID, including, but not limited to, management of a clinical sample repository.

Assess compliance with US FDA and international clinical trial standards for laboratory practices, including adherence to Good Clinical Laboratory Practices (GCLP)

Assess engagement in External Quality Assurance (EQA) programs

Assess validation and maintenance of clinical laboratory instruments

Assess performance of the Quality Management System (QMS), including protocols and systems for the efficient monitoring, prevention, and correction of quality deviations in a clinical laboratory setting

Inspect, communicate, and maintain all laboratory quality measures and deviations from quality measures

Evaluate quality plan established at international clinical research site in Uganda and advise on measures required to adhere to international standards

Assess QA/QC objectives, targets, and processes and review new targets, protocols, processes, equipment, supplies, and technologies for quality standards

Report on deviations from GCLP and international quality standards

Assist laboratory in Uganda with international accreditation efforts

Establish QA/QC documentation procedures and monitor QA/QC performance on a variety of systems by gathering relevant data from electronic and hard‑copy sources

Assure proper qualification, maintenance, and calibration of lab equipment and on‑line test instruments

Identify relevant quality‑related training needs and deliver training to personnel

Research and select appropriate regulatory and scientific resource material which will be used to support/enhance suggested actions

Support data management related activities (RedCap and FreezerPro data and sample management), including review of data management plans and follow‑up of data management issues identified through monitoring

This task will involve oversight of transfer of repository samples into barcode labeled plastic vials, which will then be inventoried using the FreezerWorks sample management system. This will require interaction and cooperation with the Office of Human Use and Ethics as well as the USAMRIID Biosafety Office.

This position requires international travel (approximately 15%), predominantly to Uganda and potentially other sites in Africa.

Bachelor's Degree in Project Management or Quality Management and/or Clinical Laboratory Management, Medical Technology, or related field

Experience with laboratory practices for international clinical trials

Minimum of three years post‑graduate experience in a life science/research Quality Control or Quality Assurance clinical laboratory developing operational performance metrics and meeting performance requirements

Familiarity with pre‑analytic, analytic, and post‑analytic processes, including both moderate and high complexity testing

work with multiple leadership and staffing levels to achieve quality management goals

Training to be provided as necessary.

Experience with international clinical trials specifically in a non‑accredited laboratory and/or austere environment

Experience with a variety of laboratory quality management systems, e.g., Demonstrated knowledge in clinical laboratory, processing, storage, and/or shipping of biological specimens; managing and designing databases and inventories; performing data checks; and/or document version control

Experience qualifying, maintaining and/or calibrating equipment strongly preferred

Experience overseeing subcontractors such as CROs, central labs, and clinical sites

Proficiency in Microsoft Office Suite

medical, dental, disability, and life insurance coverage; tuition reimbursement; and 10 paid holidays. We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans. We are proud to state that we do not discriminate in employment decisions on the basis of race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. If you are a person with a disability and you need an accommodation during the application process, please click here to request accommodation.