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MSD

Director, Bioanalytical Laboratory

Gaithersburg, MD · On-site

$114K - $149K/yr

... GCLP). • Provides leadership and management to staff consistent with applicable GLP and GCLP requirements. • Responsible for the implementation, monitoring and evaluation of performance ...

Artech Information System LLC

Bench Scientist

Cambridge, MA · On-site

$38.50 - $48.25/hr

Scientist BS with 5+ year, MS with 2+ years experienced scientist to run flow cytometry clinical samples in a GCLP environment. In addition to running clinical samples , will also be involved for ...

Artech Information System LLC

Scientist

Groton, CT · On-site

Scientist BS with 5+ year, MS with 2+ years experienced scientist to run flow cytometry clinical samples in a GCLP environment. * In addition to running clinical samples, will also be involved for ...

MSD

Senior Study Coordinator

Gaithersburg, MD · On-site

$67K - $101K/yr

... GCLP), with minimal supervision. This includes, but is not limited to, project related support by creating study-specific documentation, assisting the Bioanalytical Principal Investigators (BPIs) in ...

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How much do gclp jobs pay per hour?

As of Sep 2, 2026, the average hourly pay for gclp in the United States is $24.06, according to ZipRecruiter salary data. Most workers in this role earn between $16.83 and $25.96 per hour, depending on experience, location, and employer.

What is a GCLP professional?

GCLP professionals are individuals who work in compliance with Good Clinical Laboratory Practice (GCLP) standards. These standards ensure the quality, reliability, and integrity of laboratory data generated in clinical trials. GCLP professionals are responsible for overseeing laboratory operations, maintaining documentation, ensuring regulatory compliance, and supporting clinical research activities. Their work is critical in providing accurate laboratory results that support drug development and patient safety.

What are the key skills and qualifications needed to thrive as a Good Clinical Laboratory Practice (GCLP) professional?

To thrive as a GCLP professional, you need a solid background in clinical laboratory sciences, regulatory compliance, and quality management, often supported by relevant degrees or certifications in laboratory practices. Familiarity with laboratory information management systems (LIMS), GCLP guidelines, and audit procedures is typically required. Attention to detail, strong organizational abilities, and effective communication are important soft skills for success in this role. These competencies ensure the accuracy, reliability, and regulatory compliance of laboratory data in clinical trials, which are critical for patient safety and valid research outcomes.

What are some common challenges faced by professionals working in a GCLP role, and how can they be addressed?

Professionals in a GCLP role often encounter challenges such as maintaining stringent compliance with regulatory standards, managing documentation accurately, and ensuring effective communication between laboratory and clinical teams. Adapting to evolving guidelines and integrating new technologies can also present difficulties. Addressing these challenges involves ongoing training, robust quality management systems, and fostering a culture of open collaboration, which helps ensure data integrity and smooth workflow in clinical research settings.

What is the difference between Gclp vs Clinical Laboratory Scientist?

AspectGclpClinical Laboratory Scientist
CertificationsGCLP certification, Good Clinical Laboratory PracticeASCP certification, CLS license
Work EnvironmentClinical research labs, pharmaceutical settingsHospital labs, diagnostic labs
Industry UsagePharmaceuticals, clinical researchHealthcare, diagnostics

Gclp professionals focus on ensuring compliance with Good Clinical Laboratory Practice in research settings, while Clinical Laboratory Scientists perform diagnostic testing in healthcare labs. Both roles require laboratory skills but differ in industry focus and certifications.

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Gclp jobs near you
Infographic showing various Gclp job openings in the United States as of August 2026, with employment types broken down into 95% Full Time, 1% Part Time, and 4% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $50,049 per year, or $24.1 per hour.

Pharmaceutical - Quality Assurance

Integrated Resources INC

San Diego, CA

Contractor

Re-posted 18 days ago

Job description

Job Description

Job Description:
The individual in this position is responsible for performing day-to-day quality assurance (QA) activities, managing QA processes such as document management, internal audits, instrumentation change control, corrective and preventative actions, and assay validation planning to ensure compliance to GCLP requirements as the Client Oncology Clinical Research Laboratory (POCRL) develops, validates, and performs clinical trial assays. In addition, the position is responsible for providing QA support for clinical trial assay activities, including receipt, accessioning, and internal tracking of clinical trial biospecimens.
RESPONSIBILITIES:
Maintain, troubleshoot, and monitor the effectiveness of the POCRL's Quality Management System (QMS)
Ensure that POCRL activities conform with the requirements of the laboratory QMS
Coordinate creation, approval, implementation, and periodic reviews of Client Standard Operating Procedures for the POCRL according to GCLP guidelines
Review and approve new assay validation plans and reports according to GCLP guidelines with reference to CAP/CLIA regulations for molecular assay validation
Draft, review and approve continuing quality improvement documentation
Maintain laboratory QMS documentation in Client's document management system
Conduct annual QA audits of the POCRL & clinical trial assay processes, document findings, compose and execute Corrective and Preventative Action Plans as appropriate
Coordinate external QA audits as required and advise laboratory director of appropriate corrective actions
Serve as the POCRL's point of contact with clinical Biomarker Assay Specialist groups withing early- and late-clinical development
Ensure that the maintenance/calibration status of POCRL equipment is monitored and current
TECHNICAL SKILLS:
Ability to create and enforce laboratory standard operating procedures
Knowledge of molecular biology and laboratory safety procedures for handling hazardous chemicals and biosafety level 2 biohazard materials
Knowledge of standard molecular biology laboratory equipment
Excellent written and verbal communication skills
Ability to work independently
Ability to interface with clinical research teams
Proficiency with standard office software (Microsoft Office, Adobe Acrobat)
What is the minimum education experience required?:
BS/MS in a biological science, pharmacy, medical technology, or a related field
Medical Technology, MT (ASCP) license or equivalent (preferred)
At least 2 years' experience working in a laboratory setting that included a QMS
Good working knowledge of GCP/GCLP guidelines
Experience working in a GCP/GCLP environment (preferred)

Additional Information

All your information will be kept confidential according to EEO guidelines.

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About Integrated Resources

Sourced by ZipRecruiter

Integrated Resources Inc (IRI), based in Edison, NJ, US, is an esteemed player in the staffing solutions industry with a credible presence on their official website irionline.com. Notably, IRI provides a range of professional staffing services including contract, contract-to-hire, and direct hire solutions to a wide spectrum of industries such as healthcare, life sciences, manufacturing, financial, insurance, and others. Since its inception, IRI has been committed to delivering top-talent and optimum solutions to meet its clients' diverse needs.

Industry

Recruiting and staffing services

Company size

51 - 200 Employees

Headquarters location

Edison, NJ, US

Year founded

1996

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