At a Glance
- Tasks: Support global clinical and regulatory projects while gaining hands-on experience in diagnostics.
- Company: Join a leading research operations team in Belfast/Derry with a focus on innovation.
- Benefits: Structured training, mentorship, and opportunities for career growth in life sciences.
- Other info: Collaborative environment with a focus on professional development and team culture.
- Why this job: Make a real impact in healthcare by contributing to cutting-edge clinical investigations.
- Qualifications: Degree in Life Sciences and a passion for clinical research and project management.
The predicted salary is between 25000 - 32000 £ per year.
Location: Belfast / Derry ~ Londonderry
Job Purpose: 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. 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.
Study Coordinator TLNT1_NI in Belfast employer: ARC Regulatory Ltd
As a leading player in the diagnostics and precision medicine sectors, our company offers an exceptional work environment in Belfast/Derry~Londonderry, where you will be supported by experienced teams and receive structured development opportunities. We foster a collaborative culture that prioritises professional growth, providing mentorship from our Head of Project Management and exposure to global clinical investigations, ensuring you are well-prepared for future roles in project management and regulatory affairs. Join us to be part of a dynamic team dedicated to high-quality standards and impactful client projects.
