Clinical Research Associate

3 weeks ago

Frederick, Maryland, United States Ke`aki Technologies Full time

Job Summary:

The Clinical Research Associate - Quality Management Specialist will be responsible for reviewing and inspecting US and international clinical research and clinical trial sites engaged by Ke`aki Technologies. This individual will also assist with clinical research efforts, including management of a clinical sample repository.

Key Responsibilities:

  • 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

Requirements:

  • 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
  • Outstanding organizational skills with the ability to multi-task and prioritize
  • Familiarity with pre-analytic, analytic, and post-analytic processes, including both moderate and high complexity testing
  • Ability to build constructive and effective relationships; use diplomacy and tact
  • Ability to communicate effectively in written and oral presentations
  • Ability to function independently and as a member of a large team; work with multiple leadership and staffing levels to achieve quality management goals

Preferred Qualifications:

  • Master's Degree
  • Experience with REDCap, FreezerPro and FreezerWorks. 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., CAP, ISO, and CLIA, CLSI
  • 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

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