Contract CRA – Laboratory Monitoring (Part-Time Contract)
Location: London / South East (On-site monitoring required)
Contract Type: Freelance / Contract
Commitment: Approx. 16 hours per week
Duration: Ongoing project assignment
We are supporting a specialist diagnostics study and are seeking an experienced Contract Clinical Research Associate (CRA) with a strong background in laboratory monitoring to provide oversight of activities within a regulated molecular pathology laboratory environment.
This opportunity is ideally suited to a CRA who has experience monitoring diagnostic, IVD, or laboratory-based studies and is comfortable reviewing both operational laboratory processes and study compliance activities.
Key Responsibilities
- Conduct on-site laboratory monitoring visits at a UK-based central laboratory
- Review laboratory delegation logs, training records, competency assessments, and personnel documentation
- Assess equipment calibration, maintenance records, and temperature monitoring logs
- Review sample traceability and chain-of-custody documentation
- Evaluate laboratory compliance against study protocols, SOPs, and applicable regulations
- Review deviations, non-conformances, CAPAs, and quality management system records
- Identify, classify, and document monitoring findings
- Produce high-quality monitoring visit reports with clear recommendations and follow-up actions
- Escalate compliance risks and study issues appropriately
Essential Experience
- Current GCP certification
- Previous experience monitoring clinical performance studies, diagnostic studies, or IVD studies
- Understanding of IVDR (EU 2017/746) and/or UK MDR requirements
- Familiarity with ISO 15189 laboratory standards
- Experience conducting monitoring visits within laboratory environments (not solely clinical sites)
- Experience reviewing:
- Delegation and training records
- Equipment calibration and maintenance documentation
- Temperature excursion investigations
- Sample tracking and chain-of-custody records
- Laboratory deviations, CAPAs, and quality records
- Strong report writing and documentation skills
- Ability to independently manage monitoring activities and communicate findings effectively
Desirable Experience
- Molecular pathology or diagnostic laboratory experience
- Familiarity with DNA extraction, qPCR workflows, and molecular testing processes
- Experience reviewing assay run quality records and laboratory data outputs
- Understanding of laboratory information management systems (LIMS)
- Previous experience monitoring within NHS-affiliated or large central laboratory settings
- Knowledge of Q-Pulse or similar laboratory quality management systems
About You
You are an experienced and proactive CRA who is comfortable operating within a highly technical laboratory setting. You can identify compliance risks, communicate findings clearly, and work collaboratively with laboratory teams while maintaining an objective monitoring approach.
Interested?
Please get in touch with an up-to-date CV outlining your laboratory monitoring, diagnostics, IVD, or molecular pathology experience. Candidates with direct laboratory monitoring experience will be prioritised.