Overview
ARC Regulatory is a Belfast-based Clinical Research Organisation that specialises in delivering compliance excellence for companies in the precision medicine sector. We support 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 in parallel with our clients\' IND/IMP trial. ARC\'s team covers IVD regulatory compliance, study design and approvals, quality assurance including vendor due diligence and management, and clinical research experts who manage the IVD study to ensure it is conducted in compliance with local and global GCP and robust biomarker data. ARC360, our SaaS platform, accelerates regulatory intelligence and study-specific information for using in vitro diagnostics to select and manage patients in IND trials. It is powered by regulatory, quality, and clinical operations experts and is designed to accelerate the initiation of complex clinical trials.
Job Purpose
To be an integral member and significant contributor to ARC\'s laboratory team in the design, implementation and execution of internal and client laboratory IVD or CDX studies, ensuring that client objectives are met and exceeded at all times. This will require the utilization of regulated experimental approaches to clinical studies, internal and external stakeholder satisfaction as well as an innate work ethic that aligns with the company\'s core values.
Key Responsibilities
* Develop, optimise and validate assay protocols for molecular assays including PCR and Next generation Sequencing
* Conduct experiments to troubleshoot and refine processes to improve assay sensitivity, specificity, and reproducibility
* Conduct analysis of biomarker levels in biological samples
* Analyse and interpret experimental data, preparing comprehensive reports and presentations for stakeholders
* Stay updated with the latest advancements in relevant scientific techniques to inform laboratory activities
* Maintain accurate laboratory records and ensure compliance with safety and quality standards
* Bachelors degree in biological sciences or other related scientific subjects
* Minimum 3+ years’ experience in designing and implementing, PCR/NGS and or ELISA experiments
* Strong understanding of assay verification and validation in line with regulatory standards such as IVDR and CLSI
* Experience working within a regulated laboratory environment (ISO17025/ ISO15189 / CAPCLIA)
* Excellent interpersonal skills and presentation skills
* Excellent problem-solving skills and the ability to work independently as well as part of a team
* Able to work flexibly as required to ensure business needs are met
* Proof of Right-to-Work in the UK
* Must be able to commute daily to Belfast as job is 100% on-site
* MSC/PhD in biological sciences or other related scientific subjects
* Previous experience in a commercial laboratory
* Experience in IHC/histology
* Prior experience working in a rapid growth, SME environment
* Experience with IVDR/IDE regulation
* HEP B Vaccinated (willingness to be vaccinated at start of role)
Equal Opportunity
“We are an equal opportunity employer; applications are welcome from all and appointment will be made on the basis of merit.”
Seniority level
Employment type
Job function
Research and Science
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