We are looking for a Pharmacy Clinical Trials (Health Science) Associate Practitioner to join our Clinical Trials Pharmacy team, supporting clinical trial research across Oxfordshire.
Responsibilities
* Act as Lead Practitioner for individual clinical trials, the main point of contact once recruitment opens.
* Maintain communication with Investigators, Research Nurses, Trust R&D, Sponsors, Clinical Research Associates and Pharmacy staff during trial run.
* Manage communication with research patients, resolving concerns.
* Assist with preparation for monitoring meetings, audits and inspections.
* Maintain clinical trial files and ensure traceability.
* Liaise with Research Nurses to update on trial progress and stock levels.
* Generate invoices for allocated studies and support invoicing for other studies.
* Complete GCP checklists for allocated studies on a regular basis.
* Maintain Good Clinical Practice training and apply principles in clinical trial management.
* Ensure protocols and SOPs are followed during dispensing of investigational medicinal products.
* Close down allocated clinical trials within specified time frames and assist with close down of other studies.
Key Competencies
* Order, receive, acknowledge stock, pack, label, return and destroy clinical trial IMPs and other medicines.
* Dispense doses for patients in clinical trials.
* Check expiry date and maintain stock levels.
* Temperature‑monitor clinical trial stocks and manage excursions.
* Assist in collecting data as requested by Senior Clinical Trial Technician or Clinical Trial Pharmacists.
* Follow SOPs and propose changes where needed.
* Represent the Clinical Trials Team to update dispensary staff at meetings.
* Use equipment safely in the department, including the Waysafe cabinet.
* Safely handle hazardous materials: chemotherapy, GMOs, ATMPs, and other advanced therapy IMPs.
* Perform aseptic and non‑aseptic dispensing, including in a gloved isolator, assembly of components, dose preparation, and participate in clean room/isolator cleaning rota.
* Assist in environmental and physical monitoring of the CTASU.
* Maintain departmental records, training logs, environmental monitoring logs and worksheets.
Minimum Qualifications
* NVQ Level 2 in Pharmacy Service Skills or BTEC Level 2 Certificate in Principles and Practice for Pharmacy Support.
* Extensive experience in day‑to‑day management and handling of IMPs.
* GCSE level 4 or above in Maths, English and Science.
* Completed GCP training with good understanding of its impact on pharmacy responsibilities and IMP management.
* Ability to work fully gloved and gowned in an isolator.
* Ability to handle medicines safely, including deep‑frozen medicines.
* Reliable, attentive to detail, able to work accurately and consistently.
* Good interpersonal skills with all staff levels.
* Ability to work within SOPs, recognise when to escalates issues and resolve simple ones.
* Good written and verbal communication skills, accurate reporting.
* Professional approach and teamwork experience.
* Enthusiastic and responsible attitude toward work.
* Good organisational skills and prioritisation of work.
* Ability to work independently and use own initiative.
* Interest in supervising junior staff and providing training guidance.
* Plan daily tasks for assistants, students and apprentices.
* Work with hazardous medicines including ATMPs/GMOs, handle dry ice safely.
* Computer literate with Microsoft Office experience.
* Vaccination status as required by OUH occupational health/NHS.
Desirable Criteria
* Science degree (BSc).
* Experience within NHS.
* Aseptic pharmacy experience.
* Awareness of legislation and standards relating to Good Clinical Practice.
* Ability to acknowledge, appreciate and adapt to change.
* Experience working on own initiative.
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