Clinical Research Compliance Associate
Posted
Job Title: Clinical Research Compliance Associate (CRCA)
Location: London Bridge, SE1
Term: Permanent, Full-time
Salary: Competitive + Benefits (Private Medical, Private Dental, Life Assurance, Private Pension & many more)
Purpose of the job
The CRCA role primarily oversees clinical procedures and ensures accurate, complete data collection adhering to ICH GCP Guidelines, study protocols (CSPs), SOMs, SOPs, and other relevant regulations. CRCA role focuses on promoting, implementing and embedding the culture of ‘Do It Right the First Time’ for the purpose of ensuring clinical research trials and data quality integrity is upheld at the highest standard in accordance with ICH GCP and other regulatory requirements standards. The CRCA role encompasses the transformational aspects of being proactive in adherence of clinical compliance standards in all relevant aspects to clinical study.
Purpose of the job
The CRCA role primarily oversees clinical procedures and ensures accurate, complete data collection adhering to ICH GCP Guidelines, study protocols (CSPs), SOMs, SOPs, and other relevant regulations. CRCA role focuses on promoting, implementing and embedding the culture of ‘Do It Right the First Time’ for the purpose of ensuring clinical research trials and data quality integrity is upheld at the highest standard in accordance with ICH GCP and other regulatory requirements standards. The CRCA role encompasses the transformational aspects of being proactive in adherence of clinical compliance standards in all relevant aspects to clinical study.
The CRCA roles will include the management of all aspects of external monitoring visits, understand the nature of their queries and where applicable verify the validity of such queries in accordance with the ICH GCP standard requirements.
External Monitors and Clinical Research Auditors Management and Reporting:
- Support CRCMs in the delivery of induction and refresher training to EMs/CRAs to ensure Richmond processes and systems are well understood
- Coordinate and supporting CRCMs to liaise and coordinate with internal stakeholders with all aspects to EMs/CRAs site visits, ensuring the necessary documentation and information availability; and any query related activities are addressed in a timely manner.
Training and Education:
- Support and coordinate to ensure clinical research team members are up to date to the latest compliance matters and standards
- Be a point of contact for coordination and liaison for CRC team for training needs analysis and organisation of relevant training
Quality Control and Study compliance:
- Maintain a comprehensive planned quality control activities for clinical research activities.
- Perform internal data quality control to ensure:
- the quality of clinical procedures performed, and any study data collected to ensure it is complete, correct and conforms to all requirements, ICH GCP Guidelines
- accuracy of data collection for all study as per Richmond guidelines agreed by PIs and Sponsor where applicable.
- Where applicable and necessary, support in resolution of VDB/EDC queries
- Support CRC team in adoption of Risk Base Quality Management (RBQM) approach through the establishment of robust statistical process control using six sigma methodologies
- Liaising with the Medical Administration Team to ensure Research Physician query resolutions are completed in a timely and satisfactory manner.
Collaboration and Communication:
- Support CRCMs as a liaison between the research team and external monitors, facilitating communication and addressing inquiries or concerns.
Risk Management and Mitigation:
- Manage and maintain risks associated dataset with clinical research activities primarily in compliance perspective
Continuous Improvement and Monitoring:
- Collate and evaluate the effectiveness of the compliance program supporting CRC team performance
- Collectively work with CRCMs to Implement process improvements and best practices
Documentation and Reporting:
- Maintain documentation of compliance activities, audits, and corrective actions.
- Support preparation of compliance reports to the study team, and other stakeholders
- Support in maintaining the tracking of protocol deviations list and undertake trend analysis
- Escalate to Quality Assurance (QA) team for any non-compliance issue and support the investigation, resolution and corrective actions if applicable.
- BSc or above in Life Sciences, Nursing or Pharmacy (not necessarily registered in the UK)
- Good knowledge of ICH GCP guidelines
- Good knowledge of MHRA early phase accreditations
- Previous data monitoring experience in CRO or pharma for clinical trials (Desired)