Availability: Dependent on length, timescale and scope of project
Main Expertise
Quality Assurance
Location and Availability
UK
Contact us
For more details on individual profiles and their availability please email kubosourcing@crosnt.com
Tel: +44 (0) 1908 488787
Profile #1101181
Profile #1101181
Key Skills
- GCP Auditor
- Quality Assurance (QA) Consultant
- Worldwide audits
- TMF audits
- Phase I facility audits
- Clinical site audits
- Sponsor audits
- CRO audits
- Preparation for Regulatory Authority inspections
Experience
- 34+ years’ experience within clinical trials
- 28+years’ experience as a freelance GCP Auditor and Quality Assurance Consultant
- Consultancy services to pharmaceutical companies and CROs
- Preparation for Regulatory Authority inspections (UK, USA, EMA)
- Planning and conducting phase I-IV clinical study site, sponsor, and CRO audits
- GCP audits performed in 43 countries to date including UK, EU, Australia, Russia, South Africa, Argentina and USA
- Trial Master File Audits
- Phase I facility audits
- CRO facility audits
- Investigation of alleged fraud in clinical research and for Cause Audits
- Archive facility audits
- Phases: I-IV
Education
- MA (Cantab)
- BA (Hons) Natural Sciences