Study Coordinator
Apply Here - Study Coordinator
About ARC
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.
The Study Coordinator will act as an integral member of the Research Operations team, supporting the delivery of global regulatory and clinical projects across the diagnostics and precision medicine sectors.
Job Purpose:
This graduate role is designed to provide structured development across clinical operations and regulatory affairs, enabling the Study Coordinator to build a broad understanding of global In Vitro Diagnostic (IVD) and Companion Diagnostic (CDx) development pathways.
Working alongside experienced Regulatory and Clinical teams, the Junior Study Coordinator will support the coordination and delivery of client projects, assist with project planning and operational activities, contribute to regulatory and clinical documentation and help ensure projects are delivered in line with client expectations, timelines and ARC’s high-quality standards.
Additional mentoring support will be provided by the company’s recently appointed Head of Project Management.
The role will provide exposure to global clinical investigations, performance studies, regulatory submissions and operational project delivery, while developing strong organisational, communication and stakeholder management skills within a regulated environment.
This position is designed as a development pathway into future roles within project management across clinical operations, regulatory affairs or broader translational diagnostics programmes.
Key Responsibilities:
Study Coordination
- Support the delivery of regulatory and clinical projects across multiple client programmes.
- Assist project leads with project coordination activities including timelines, task tracking, meeting coordination and action management.
- Help monitor project deliverables and support teams in meeting client timelines and objectives.
- Support prioritisation of project activities across multiple concurrent programmes.
- Assist with maintaining project documentation, trackers and operational records.
- Participate in internal and client project meetings, preparing minutes and tracking follow-up actions where required.
- Build strong working relationships with internal teams and contribute to effective communication across projects.
Clinical Operations Support
- Support the set-up, management and coordination of global clinical investigations and IVD performance studies.
- Assist in preparing clinical and operational documentation.
- Assist with audit preparation and quality management system activities.
Regulatory Affairs Support
- Assist in preparing sections of regulatory submissions.
- Support development of regulatory and technical documentation.
- Gain awareness of global regulatory requirements relating to IVDs and companion diagnostics.
- Support maintenance of internal regulatory intelligence resources and tools.
Business Support
- Support preparation of client-facing reports, presentations and project materials.
- Assist with internal process improvement and operational development initiatives.
- Contribute to ARC company culture initiatives and team activities.
- Support wider business functions where required as part of a collaborative team environment.
Professional Development
- Undertake structured training and development across clinical operations, regulatory affairs and project management.
- Develop knowledge of global regulatory frameworks, GCP standards and diagnostics industry requirements.
- Demonstrate a proactive and growth-focused approach to learning and development.
- Maintain awareness of evolving industry, clinical and regulatory standards.
- Build capability across both Regulatory and Clinical Operations disciplines.
Essential Criteria
- Degree within Life Science subject
- Strong interest in clinical research, diagnostics, regulatory affairs or project management within the life sciences sector.
- Excellent interpersonal and communication skills.
- Strong organisational and time management abilities.
- Attention to detail and commitment to quality.
- Strong analytical and problem-solving skills.
- Ability to manage and prioritise multiple tasks effectively.
- Confidence working within multidisciplinary teams.
Desirable Criteria
- MSc or PhD in science related subject
- Project Management Qualification
- Placement year or internship within medical devices, diagnostics, pharmaceuticals or healthcare.
- Understanding of medical devices, IVDs, companion diagnostics or clinical research principles through academic study or placement experience.
- Familiarity with quality management systems or operational processes.
- Understanding of project management principles or tools.
- Awareness of regulatory or clinical standards such as GCP, ISO standards or EU/FDA regulations.
“We are an equal opportunity employer; applications are welcome from all and appointment will be made on the basis of merit.”