Clinical Research Associate

Ke'aki Technologies; Frederick (MD); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

401K match

Health insurance

Tuition reimbursement

Paid holidays

Paid vacation and sick time

Job summary

Laulima Government Solutions LLC is seeking a QA/QC professional to review international clinical trial sites and assist with clinical sample repository management. The role emphasizes GCLP compliance, QA/QC documentation, and coordination with Human Use and Ethics offices.

The candidate should have a Bachelor’s degree in Project Management or Quality Management, at least three years post-graduate life science QA experience, and strong communication and organizational skills.

Qualifications

• Bachelor's Degree in Project Management or Quality Management or related field.
• Minimum of three years post-graduate experience in a life science/research Quality Control or Quality Assurance clinical laboratory.
• Experience with laboratory practices for international clinical trials.
• 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 relationships; use diplomacy and tact.

Responsibilities

• Review international clinical trial sites for compliance with FDA and GCLP.
• Assess engagement in External Quality Assurance (EQA) programs.
• Inspect validation and maintenance of clinical laboratory instruments.
• Monitor and improve Quality Management System (QMS) processes.
• Maintain QA/QC documentation and report deviations.
• Coordinate sample repository transfers and barcode labeling.
• Travel internationally about 15% to Uganda and other sites.

Skills

QA/QC in clinical labs

Regulatory compliance

Organizational skills

Communication

Team collaboration

Travel readiness

Education

Bachelor's Degree in Project Management or Quality Management

Clinical Laboratory Management related field

Tools

REDCap

FreezerPro

FreezerWorks

Microsoft Office Suite

Job description

Description of Responsibilities

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.

Tasks include

• 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. Samples must then be linked to clinical subject files. 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.

Degree/Education/Certification Requirements

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

Required Skills and Experience

• 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

Desired Skills and Experience

• Master's Degree preferred
• 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

Laulima Government Solutions LLC is a fast growing government service provider. Employees enjoy competitive salaries; a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid vacation and sick time; and 10 paid holidays. Laulima Government Solutions is proud to be an equal opportunity employer.

For additional information on Laulima Government Solutions, LLC, please visit www.laulimags.com.

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. We E-Verify all employees.