Who are we?
Clerkenwell Health is an innovative and leading Research Organisation specialising in the delivery of scientifically grounded Clinical Trials using its collaborative Contract Research Organisation (CRO), extensive Clinical Research Facility (CRF) Network, and leading Therapy Development Program. Clerkenwell Heath specialises in the supporting the Mental Health and CNS (Central Nervous System) space with a focus on Psychedelic drug development.
The Role
The Clinical Trial Pharmacist and Home Office Compliance Officer will work alongside experienced clinical research staff within the unit and clinical team. The post holder will provide Pharmacy support for clinical trials running in our units. This will involve work on clinical research trails and will be focussed on delivering high quality patient care in the process of executing efficient Phase I-III clinical trials. Support the timely delivery of clinical studies to acceptable medical standards, in-line with the requirements of sponsors, ICH GCP, and other appropriate guidelines and regulations.
What will the Role entail?
- Lead and maintain the Pharmacy Clinical Trials service in compliance with UK Clinical Trials Regulations, GCP, GMP, GDP, and ICH guidelines
- Oversee the setup, maintenance, and archiving of clinical trials, and ensure trial amendments are reviewed, processed, and checked accurately
- Develop strong working relationships with the management team, Principal Investigators, research teams, and pharmacy staff
- Use expertise to identify areas for improvement in clinical research practices to enhance study delivery and participant engagement
- Provide pharmacy input on trial feasibility, share good practices, and support non-medical clinical research teams
- Represent the clinical trials pharmacy team in educational, training, and other relevant meetings
- Lead Investigator Meetings, Site Initiation Visits, and Pre-Study Selection Visits, and manage source document development
- Act as the main contact for site staff, study sponsors, and clinical research organizations, leading feasibility activities and essential documentation reviews
- Manage and allocate workload across the team, and support senior managers with HR tasks like recruitment and line management
- Coordinate and deliver training for new and existing staff, including external teams, to ensure knowledge sharing and best practices
- Oversee all aspects of IMP management, including procurement, storage, dispensing, and compliance with legal requirements and GCP standards
- Ensure compliance with Home Office regulations for controlled drugs, conduct audits, and support Home Office applications and inspections
- Complete mandatory and professional development training to maintain high competency in clinical trials service
What will you need to succeed?
- MPharm degree or equivalent
- Postgraduate qualification in Clinical Pharmacy or similar/equivalent
- GPhC registered pharmacist
- Evidence of continuing professional development
- Formal training in Good Clinical Practice (GCP)
- Annex 13 training
Interview Process
There will be an initial screening call with the recruiter, followed by a 2 stage process with the Lead Pharmacist & doctor on site.
Is this the role for you?
Our values at Clerkenwell Health are Compassion, Collaboration, Innovation & Integrity. If the above role resonates with you & you align with our values then we would love to hear from you! Best of luck