Job Specifications
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.
Role Overview
This placement provides an exciting opportunity for a motivated student to gain hands-on laboratory experience in a high-quality, regulated laboratory environment. The successful candidate will support key research and development activities, including assay validation, pre-clinical assay revalidation, and routine laboratory management tasks. This role will allow the student to work closely with experienced scientists and contribute to real-world applications of diagnostic technology.
Key Responsibilities
Assistin the development, validation, and revalidation of diagnostic assays (IHC, PCR, ELISA).
Support the transfer of pre-clinical biomarker assays to ARC Research Laboratories, ensuring compliance with US FDA IDE and EU IVDR regulations.
Participate in transitioning research-use-only (RUO) assays to investigational-use-only (IUO) and IVDR-compliant formats.
Contribute to the routine maintenance and installation of laboratory equipment.
Follow Good Clinical Practice (GCP) guidelines and ensure compliance with relevant quality and regulatory standards (CAP CLIA, and ISO 17025).
Support routine laboratory tasks, including sample preparation, data recording,stockand order management
Work collaboratively with research scientists, regulatory teams, and clinical trial partners tohelpensure projectobjectivesare met.
Key Skills & Competencies
Currently pursuing a degree in Biomedical Science, Molecular Biology, Biochemistry, or a related field.
Strongbasiclaboratory skills, withinterest in developingexperience in molecular and immunological techniques (PCR, ELISA, IHC)preferred..
Ability to work independently and within a team in a fast-paced research environment.
Excellent attention to detail and strong analytical skills.
Effective communication and organizational skills.
What We Offer
Hands-on experience in a cutting-edge diagnostic research laboratory.
Exposure to regulatory and quality assurance processes in a highly regulated industry.
Mentorship from experienced professionals in diagnostic technology and clinical research.
An opportunity to contribute to meaningful research thatimpactspatient care and clinical trials.
We are an equal opportunity employer; applications are welcome from all and appointment will be made on the basis of merit.
Skills
IVD Labratory skills
Benefits
Parking
About the Company
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 diagnosti...
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