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.
To further support our growing client base and to expedite patient access to life-saving experimental medicines, ARC has developed and launched our SaaS platform, ARC360. ARC360 is transforming how organisations access regulatory intelligence and tailor study-specific information for using in vitro diagnostics to select and manage patients in IND trials. Powered by cutting-edge technologies and supported by a team of regulatory, quality, and clinical operations experts, ARC360 is designed to accelerate the initiation of complex clinical trials.
Job Purpose
To be an integral member and significant contributor to ARCs 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 graduate role is designed to develop future leaders within ARC laboratory providing exposure to assay design and development, clinical testing and regulatory affairs. The graduate scientist will contribute to client deliverables, while developing a broad understanding of IVD validation and GCP/GLP clinical testing in a quality driven accredited laboratory.
Key Responsibilities:
The R&D Scientist is expected to:
* Participate in the optimisation and validation of molecular assays including Next generation Sequencing and PCR
* Conduct analysis of biomarker levels in biological samples.
* Analyse and interpret experimental data, preparing comprehensive reports and presentations for stakeholders.
* Maintain accurate laboratory records and ensure compliance with safety and quality standards
* Stay updated with the latest advancements in relevant scientific techniques to inform laboratory activities.
* Undertake structured training and development in laboratory operations and assay validation
* Demonstrate a growth mindset, proactively seeking opportunities to expand knowledge and capability.
* Contribute to ARC’s positive, collaborative and high-performing company culture
Essential Criteria:
* Bachelors degree in biological sciences or other related scientific subjects
* Practical laboratory experience (academic or industry) in molecular and/ techniques such as PCR and NGS
* Basic understanding of assay verification and validation principles, with awareness of regulatory frameworks
* Excellent interpersonal skills
* Excellent communication skills, both verbal and written, including strong presentation and influencing skills
* Evidence of strong analytical, problem solving and decision-making abilities
* Proven ability to achieve results while working independently and on own initiative
* Strong mathematical ability
* Strong attention to detail and commitment to quality
* Proficient in the use of word processing, spreadsheet, database, and presentation software
Desirable Criteria:
* Masters in biological sciences or other related scientific subjects
* Academic or industry placement year
* Experience in IHC/Histology
* Interest in regulatory requirements (e.g. IVDR/IDE) and willingness to develop knowledge in this area
“We are an equal opportunity employer; applications are welcome from all and appointment will be made on the basis of merit.”