Overview
Are you a Pharmacy Technician looking for a new challenge or with an interest in research? Are you passionate about making a real impact on the lives of cancer patients? Do you have a keen eye for detail, and a desire to be at the forefront of oncology research?
We are not specifically seeking those with hospital or clinical trials experience; several members of our team have joined from outside of hospital backgrounds. We are more interested in your ability to show drive, ambition, willingness to learn, manage workload, organisational and team working skills. If you are newly qualified, we welcome applications and would offer a band 4 to band 5 progression post until competencies and accuracy checking qualifications are complete.
Responsibilities
* Communicate professionally with staff on all levels, both internal and external relating to trial activities, regarding information which may be confidential and sensitive in nature.
* Communicate with sponsors for monitoring appointments and meetings verbally and in written format.
* Liaise with other health professionals within research teams providing advice and support pertaining to clinical trial pharmacy issues.
* Exercise judgement when dealing with all enquiries. Assess and manage query if possible, referring to the Lead clinical trials technician, senior trials technicians or pharmacists as appropriate.
* Check pharmacy files for missing data and organise, retrieve, and record data in a timely manner.
* Co-ordination of monitoring visit requests, ensuring availability of staff and workspace.
* Ensuring clinical trial pre orders and vial allocations are turned around in a timely fashion to prevent any delay in patient treatment.
* Support co-ordination of study set-up with the clinical trials pharmacist in a timely manner.
* Work with sponsor IVRS/IWRS for ordering, acknowledging orders, dispensing update calls for Investigational Medicinal Products.
* Supports the generation of worksheets and labels for Investigational Medicinal Products for both Aseptics and the Dispensary.
* Dispensing and preparation of medicines for clinical trials in accordance with departmental and study specific SOPs.
* To act as a certified accredited checking technician, supporting the final check of clinical trial prescriptions.
* To provide support to other pharmacy staff in the dispensing of complex clinical trials.
* Support and advise key staff accordingly in relation to handling, labelling, and dispensing for all new products used in clinical trials.
* Ensure all trial related reports and documentation are maintained within the timeframes defined by the sponsor.
* Follow all relevant policy and legislation (e.g., EU Directive).
* Prepare master worksheet and labels for approval by appropriate pharmacists using Sponsor supplied documents.
* Awareness of COSHH regulations in the safe handling and storage all clinical trial materials.
* Assists SATO, Student Technicians, and the CTA in ensuring supplies of Investigational Medicinal Product are ordered in a timely manner.
* Use computer-based data storage systems and IVRS/IWRS to record clinical trial activity.
* Work with Microsoft Office programmes, requiring standard software skills.
* Maintain individual patient treatment records on Trust based systems, ensuring information is up to date, accurate and complies with Data Protection Act.
* Assist pharmacy team in all areas of R&I administration as required.
* Ensure all drug accountability for all clinical trials are processed accurately and in a timely manner ensuring drug accountability is up to date at the time of a monitoring visit, audits, and Inspections.
* Assist the ATO/CTA in maintenance of pharmacy documentation where required.
* Support regulatory compliance across all clinical research services within pharmacy.
* Post holder is expected to follow all relevant protocols, SOPs, and standard practice.
* Clinical Trials Team Leader is available as point of reference for any queries and will meet regularly with staff.
* Plan and organise own time and workload activity with prioritisation.
* Participate in extended hours of the department, if required. To be able to participate in weekend and bank holiday working as required by the service.
* Ability to demonstrate the organisational values and behaviours and the positive working relationship policy.
* Support all aspects of pharmacy requirements to set-up clinical trials.
* Provide support to the clinical trials lead technician to ensure activities within the pharmacy department are managed in accordance with the International Conference of Harmonisation Good Clinical Practice Guidelines (ICH-GCP), Good Manufacturing Practice (GMP), the Research Governance Framework for Health & Community Care (2001) and the Medicines for Human Use (Clinical Trials) Regulations 2004.
* Support the clinical trials lead technician and clinical trials pharmacist with internal, external audits and regulatory inspections by the Medicines and Health Regulatory Authority (MHRA) within pharmacy.
* The Christie is one of Europe’s leading cancer centres, based in Manchester, with a broad portfolio of oncology research and collaborations.
Qualifications
* Educated to NVQ level 3/BTEC in pharmacy services or equivalent.
* Ability to fulfil a role as an accredited checking technician within our purpose-built clinical trials dispensary.
* If you do not have an accredited checking technician qualification but are an exceptional candidate or are working towards then please get in touch to discuss further.
* Newly qualified Pharmacy Technicians are welcome; progression to band 5 may be offered post-appointment until competencies are complete.
About The Christie / Working at The Christie
The Christie is one of Europe’s leading cancer centres, treating thousands of patients with a strong focus on oncology research. We are based in Manchester and collaborate with the University of Manchester. The Pharmacy Department supports a large-scale portfolio of clinical trials and has strong links with research partners. Training will be provided to help manage a portfolio of clinical trials and you will work with the clinical disease teams and research teams to ensure patients have access to investigational medicines.
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