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- To help manage, develop, organise and maintain the Oncology Pharmacy Clinical Trials Portfolio in conjunction with the Highly Specialist Clinical Trials Pharmacist, ensuring compliance with ICH GCP guidelines, The Research Governance Framework, the E.U Clinical Trials Directive and other relevant guidelines, regulations and policies.
- To help manage the training and assessment of pharmacy staff undertaking Clinical trial work within Oncology Pharmacy
- Develop, review & revise policies, guidelines and procedures regarding clinical trials services
- To write precise and concise standard operating procedures (SOPs) for each new clinical trial with respect to dispensing, final checking and procurement of Investigational Medicinal Products (IMPs) which are final checked by the Highly Specialist Clinical Trials Pharmacist.
To be responsible for the day-to day maintenance of the oncology pharmacy clinical trials portfolio.
Ensuring that all oncology pharmacy clinical trial files contain all necessary documentation and are kept up to date
Preparing (and update as required) clear and accurate written dispensing procedures for dispensing staff for each clinical trial in accordance with International Conference for Harmonisation for Good Clinical Practice( ICHGCP) and each study’s protocol
Preparing (and update as required) clear & accurate final checking procedures for rotational pharmacists in accordance with ICH GCP and each study’s protocol
Prepare (and update as required) a clear and accurate written summary of each clinical trials protocol.
Create drug accountability records, patient I.D logs and other documents deemed necessary (where the study sponsor has not already provided)
Ensure that all files contain copies of all relevant regulatory approvals
Review oncology clinical trial documents prior to initiation of a new study, assess the suitability local documents and procedures relating to procurement, storage and dispensing of study medication and make recommendations for changes when appropriate.
Dispensing clinical trials
Manage the security & maintenance of all clinical trial drugs
Responsible for routine monitoring visits and ‘close down’ procedures for clinical trials
As part of Kings Health Partners, the Oncology and Haematology Clinical Trials (OHCT) team is made up of ninety plus staff members consisting of Research Nurses, Clinical Trial Practitioners, Clinical Trial Coordinators and the Safety & Support Team at Guys’ and St Thomas’ NHS Foundation Trust. Within the OHCT Pharmacy team there is a mixture of pharmacists technicians and assistant.
We work closely with the oncology and haematology medical teams to recruit patients to our trials and to ensure patients are monitored closely throughout. We have a large portfolio of Phase II and III trials; which are split into teams for specific tumour groups. We also have a team dedicated to early phase trials and run weekly early phase clinics in the Clinical Research Facility. We attract commercial and non-commercial trials, ranging from interventional drug or radiotherapy trials to observational studies.
Our mission statement is ‘Improving treatment choice, clinical care and outcomes for cancer patients through innovation, dedication and excellence in clinical trials’.
For further details / informal visits contact: Name: Amit Agravat Job title: Highly Specialist Pharmacist - OHCT Email address:
[email protected]
