ARC's purpose is to expedite access to precision medicine clinical trials for patients globally. We fulfil our purpose through our dedicated team of experts with unparalleled domain knowledge, and the important relationships we have developed with our global clients.
We are a Belfast-based Clinical Research Organisation that specialises in delivering compliance excellence for companies in the precision medicine sector. We support many of the world's leading pharmaceutical R&D companies in implementing unapproved diagnostics in their clinical development programmes for patient selection or stratification, working as a strategic and integrated expert partner, taking full sponsor ownership of the IVD study being conducted in parallel with our clients' IND/IMP trial.
ARC's team of experts cover IVD regulatory compliance, study design and approvals, quality assurance including vendor due diligence and management along with a team of clinical research experts who manage the IVD study, ensuring it is conducted in compliance with local and global GCP, and that the biomarker data is robust and reliable.
Job Purpose
ARC Regulatory Laboratory is seeking a qualified and experienced Contract Clinical Scientist -molecular specialist to support our central testing laboratory services for health institutions and clinical research studies. The role acts as a subject-matter expert and trusted advisor to internal teams, sponsors, and external partners, ensuring all testing activities are scientifically robust, clinically appropriate, and compliant with applicable regulatory, accreditation, and quality standards.
The clinical scientist is responsible for providing clinical and scientific oversight across the assay lifecycle, from development and validation through to clinical implementation and ongoing performance monitoring, while supporting sponsor interactions, protocol alignment, and risk management. The role contributes to strategic decision-making, continuous improvement, and the maintenance of the laboratory’s reputation as a reliable, high-quality central testing partner.
The role will include the evaluation and interpretation of ELISA and qPCR data, with experience in NGS data interpretation and assay validation considered advantageous. Contract Pathologists will provide clinical oversight and scientific interpretation and reporting aspects of diagnostic and companion diagnostic (CDx) development as well as ARC’s eQMS and internal procedures.
Key Responsibilities
- Provide expert review and interpretation of ELISA, qPCR and if possible NGS data for use in patient management decisions in IVD clinical trials. Issue/review clinical test reports.
- Review and approve assay verification/validation reports and related documentation in compliance with GCLP, ISO15189, IVDR, HTA and CAP/CLIA.
- Review and approval of internal risk assessments, with particular focus on patient safety.
- Participation in annual Laboratory Management Review meetings.
- If required, contribute to data interpretation alignment meetings
- Provide clinical oversight of ARC Labs eQMS including but not exclusively:
- Provide defined clinical governance oversight for assigned assays, including review of EQA and IQC performance, assessment of clinically significant non-conformances, and input to root cause analysis and CAPA effectiveness, with escalation to the Laboratory Director where patient safety or result integrity may be impacted.
- Contribute a clinical perspective to ongoing assay performance monitoring, including review of relevant quality indicators, trend analysis, and participation in investigations of complaints, incidents, or amended reports with potential clinical impact.
- Maintain professional competence and registration, and contribute as required to management review, internal audit findings, and risk assessments relevant to molecular testing services in accordance with ISO 15189.
Essential Criteria
- Doctorate (PhD preferred) in a relevant scientific discipline or Msc in clinical science
- Professional HCPC clinical scientist
- If Principal must have MRC Path
- Minimum of 3 years post registrational experience
- Experience in qPCR, ELISA assays and interpretation
- Familiarity with regulatory standards – ISO15189, IVDR, CAP CLIA and GCLP
- Able to work flexibly as required to ensure business needs are met.
- Role may require onsite visits to ARC laboratories
Desired Criteria
- Previous experience in oncology and biomarker studies
- Experience with Roche cobas platform and ADA ELISA assays
- Experience with multiplex NGS assays on illumina platforms
Additional Information:
This is a flexible, contract-based role targeted to UK and Ireland based clinical scientists. Transparent availability and capacity to support project- specific deadlines and turn around is essential. Confidentiality and data protection will be strictly adhered to. Responsibility of clinical scientist to determine any pre-existing conflicts of interest with pre-existing employment. All conflicts of interest must be declared. Current expectation is contract will be a maximum of 10 h per month.