Clinical Research Associate

Camwebdir; United Kingdom; Remote; GBP 38,000 - 60,000; Full time

Benefits offered by this job

25 days holiday

Pension contribution

Competitive salary

Job summary

The Origin Group Ltd (TOGL) is seeking a Study Monitor/Clinical Research Associate to oversee clinical studies in line with approved protocols, GCP and sponsor SOPs. You will monitor sites, protect participants and ensure data integrity across UK studies.

Reporting to the Head of Clinical Operations, you will conduct site visits (remote or on-site), review informed consent and source data, manage trial documentation, and escalate issues to keep studies on track while upholding high standards and

Qualifications

• Minimum 3 years' experience as a CRA 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.
• Ability to identify and elevate issues affecting participant safety, data integrity or protocol compliance.
• Excellent written communication skills and high-quality monitoring reports.

Responsibilities

• Conduct site monitoring activities, including site initiation, interim monitoring and close-out visits, remotely or on site.
• Verify informed consent documentation is complete, accurate and compliant.
• Review source data and eCRF data in line with monitoring plans, focusing on critical data and endpoints.
• Assess site compliance with protocols, GCP, regulations, ethics approvals and sponsor procedures.
• Review Investigator Site File documentation and ensure documents are complete and inspection ready.
• Check delegation and training logs to confirm staff are trained and delegated appropriately.
• Identify and follow up protocol deviations, data quality issues and monitoring findings.
• Support sites with query resolution, data entry timelines and process adherence.
• Review adverse events and device deficiencies, ensuring timely reporting where applicable.
• Maintain monitoring visit reports, follow-up letters and action logs.
• Escalate significant or recurring issues to the Clinical Study Manager or sponsor.
• Support risk-based monitoring activities and central site performance reviews.
• Contribute to audit and inspection readiness, including CAPA support.
• Build effective working relationships with site teams, investigators and data teams.

Skills

Written communication

Attention to detail

Independent working

Stakeholder management

NHS collaboration

Job description

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 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