R&D Auditor and Compliance Specialist

4 weeks ago


London, Greater London, United Kingdom NHS Full time
R&D Auditor and Compliance Specialist

We are seeking an experienced R&D Auditor and Compliance Specialist to join our team at Guy's and St Thomas' NHS Foundation Trust. The successful candidate will be responsible for developing, implementing, and maintaining sponsor oversight management systems, including audit plans, to ensure the quality of clinical research sponsored or co-sponsored by GSTT.

Main Responsibilities
  • Develop and implement sponsor oversight management systems, including audit plans, to ensure the quality of clinical research sponsored or co-sponsored by GSTT.
  • Conduct audits and monitoring activities to ensure compliance with regulatory requirements and Good Clinical Practice (GCP) principles.
  • Collaborate with the R&D sponsorship team to ensure effective risk management during the set-up process.
  • Develop and maintain a clinical trial and GCP audit and monitoring programme to improve the R&D Quality Management System (QMS).
  • Provide training and support to staff on GCP and regulatory requirements.
Requirements
  • Educated to at least degree level in a related subject area, e.g. life science or clinical subject.
  • Evidence of ICH GCP Audit and Monitoring Training.
  • Experience in monitoring and auditing, coordination or managing clinical trials to GCP in a pharmaceutical company, contract research organisation, NHS or academic setting.
  • Risk and incident management experience in the NHS or pharmaceutical industry environment.
  • Experience of managing a team.
Working Arrangements

This is a part-time job with flexible working arrangements, including compressed hours. The post-holder will be required to work in the R&D office at Guy's hospital a minimum of one day a week and may be required to attend more frequently to support the team and conduct on-site audits.

Salary and Benefits

The salary for this role is £61,927 to £68,676 a year, inclusive of HCA pro rata.

Contract and Working Pattern

This is a permanent part-time contract with flexible working arrangements.



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