Clinical Research Associate

About The Origin Group Ltd (TOGL): The Origin Group Limited (TOGL) is the parent organisation and technical service provider to a focused portfolio of UK-based medical technology, research, and innovation companies. Organisations within the group include Origin Sciences, Ellele Health and Biomii. Origin Sciences is a clinical-stage diagnostics company developing and commercialising novel medical devices for gastrointestinal diseases. Our proprietary sample collection technology underpins innovative diagnostic solutions across multiple diagnostic areas with a focus on colorectal cancer. Ellele Health is focused on advancing women’s health by developing a novel vaginal sample collection device for gynaecological diagnostics, including the early detection of endometrial cancer. As a group, we are committed to delivering cutting-edge diagnostic tools that empower clinicians, improve patient outcomes, and transform standards of care.

Role Overview: Reporting to the Head of Clinical Operations, the Study Monitor / Clinical Research Associate is responsible for monitoring clinical studies to ensure they are conducted in accordance with the approved protocol, GCP, applicable regulations, sponsor SOPs and study-specific requirements. The role provides proactive oversight of study sites, supports high-quality participant protection and data integrity, and ensures that issues are identified, documented, escalated and resolved in a timely and proportionate way. The post-holder will play a critical role in ensuring TOGL clinical studies are delivered safely, efficiently and to a high standard.

Key Responsibilities:

• Conduct site monitoring activities, including site initiation, interim monitoring and close-out visits, either remotely or on site.
• Verify that participants have been consented appropriately and that informed consent documentation is complete, accurate and compliant.
• Review source data and eCRF data in line with monitoring plans, with particular focus on critical data, eligibility, safety reporting, sample/device accountability and endpoint data.
• Assess site compliance with protocols, GCP, applicable regulations, ethics approvals and sponsor procedures.
• Review Investigator Site File documentation and ensure essential documents are complete, current and inspection ready.
• Check delegation and training logs to confirm that study activities are performed only by appropriately trained and delegated staff.
• Identify, document and follow up protocol deviations, non-compliance, data quality issues and monitoring findings.
• Support sites with query resolution, data entry timelines and study process adherence.
• Review adverse events, serious adverse events and device deficiencies, where applicable, ensuring reporting is complete and timely.
• Maintain clear and accurate monitoring visit reports, follow-up letters and action logs.
• Escalate significant or recurring issues to the Clinical Study Manager, Sponsor or relevant study lead.
• Support risk-based monitoring activities, including central review of site performance, recruitment, data completeness, query trends and deviation patterns.
• Contribute to audit and inspection readiness, including preparation, follow-up and CAPA support.
• Build effective working relationships with site teams, investigators, research nurses, data teams and internal study stakeholders.

Essential:

• Minimum 3 years’ experience as a CRA, Study Monitor or equivalent clinical research monitoring role.
• Strong working knowledge of ICH-GCP and UK clinical research governance requirements.
• Experience conducting remote and/or on-site monitoring visits.
• Experience reviewing informed consent, source data, eCRFs, ISF documentation, delegation logs and safety reporting.
• Ability to identify and elevate issues affecting participant safety, data integrity or protocol compliance.
• Strong written communication skills, including high-quality monitoring reports and follow-up letters.
• Excellent attention to detail and ability to manage competing site priorities.
• Confident working independently while maintaining clear escalation and oversight.
• Good stakeholder management skills and ability to work constructively with NHS site teams.

Desirable:

• Experience in medical device, IVD, diagnostics or non-CTIMP studies.
• Experience with risk-based monitoring approaches.
• Familiarity with ISO 14155.
• Experience supporting audits or regulatory inspections.

Benefits: 25 days holiday, Pension contribution, Competitive salary.