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 OverviewReporting 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 ResponsibilitiesConduct 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.RequirementsEssentialMinimum 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 escalate 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.DesirableExperience 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. Benefits25 days holidayPension contributionCompetitive salary
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.
Requirements
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 escalate 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
