Senior Ato Clinical Trials and Production Services

6 months ago

Plymouth, United Kingdom University Hospitals Plymouth NHS Trust Full time

We are currently seeking a Senior Assistant Technical Officer to join the Pharmacy Clinical trials team, who is self-motivated and able to work well as part of a team and motivate others, and has the ability to be professional, reliable and treat others with respect and dignity.

The post holder will be responsible for helping with the organisation of the clinical trial aspect of the workload within the Pharmacy Production Services dept.

You will assist, under supervision, with routine duties of a technical nature, including the dispensing and supply of trial and supportive medication to in
- and out-patients, ordering, receipt, processing, storage and stock control of the clinical trial medicines, closing down and archiving of completed studies, as well as facilitating meetings from sponsors.

You will respond to enquiries and requests from staff, patients and carers as appropriate.

**For further information please contact**:
Mike Marner

Pharmacy Trials Manager

01752 432280

To assist the Clinical Trials and Research Pharmacist in all aspects of clinical trials and ensure compliance with current national legislation, the International Conference of Harmonisation Good Clinical Practice (ICH GCP) guidance and the Research Governance Framework (2005) in the conduct of clinical research.

Undertake technical duties in the preparation of manufactured pharmaceuticals within the Pharmacy Production Services to ensure all research products are prepared to a high standard as set out in study specific documents, standard operating procedures and appropriate guidelines.

**Preference will be given to internal Trust staff, as well as ‘ Priority ’ and 'At Risk' status including NHS At Risk staff throughout Devon who are able to display recent relevant experience as dictated by the Person Specification.**

1. To prepare and prioritise cancer chemotherapy and medicines for injection including GMO class 1 and 2, using laminar airflow cabinets or isolator technology, providing all necessary in-process checks, within the clean room environment under the guidance of good manufacturing practice.

2. To prepare cancer chemotherapy for intrathecal use according to Department of

Health guidelines, local trust policy and departmental procedures.

3. To work unsupervised if necessary in the preparation of cancer chemotherapy.

4. To follow carefully all standard operating procedures to ensure all products are made safely and efficiently in accordance with Good Manufacturing Practice legislation and guidelines.

5. To prepare all types of product documentation, with all types of calculations and the production of labels using the Prisym 2000 label software.

6. To assemble the raw materials and consumables required to prepare each individual product, ensuring total segregation of each preparation using a box or tray segregation system as defined in the standard operating procedure.

7. To assist with Clinical Trial stock control to include the production and checking of routine stock checks, ensuring stock rotation and expiry date checks are completed and investigating stock discrepancies.

8. To complete, maintain and file all relevant documents, records and reports.

9. To clean the pharmacy aseptic suite and support rooms following standard operating procedures and using specific methods of cleaning, ensuring appropriate quality control samples are taken and cleaning logs filled out.

10. To co-operate and participate in any training and development in production services, attending such study days and courses as necessary for service development.

11. To complete any environmental monitoring or operator validation tests requested by the quality assurance manager as appropriate to Clinical Trials.

To provide effective communication with the R&D department, the research team, multidisciplinary team and various UK organisations and pharmaceutical companies.

13. To undertake general dispensary duties, in accordance with standard operating procedures and the legal framework for the supply of medicines:
Labelling - generate accurate medication labels

Dispensing - accurately dispense inpatient, outpatient and discharge prescriptions, including clinical trials, cytotoxic drugs and controlled drugs.

Issue drugs - to healthcare professionals referring for advice when necessary.

In collaboration with the pharmacy clinical trials team to ensure accurate record keeping of drug accountability of all clinical trials (both written and computer records). Reporting any exceptions of deficiencies to the pharmacy clinical trials support manager.

To contribute to the efficient stock control of all clinical trial products by undertaking regular stock checks to ensure sufficient (IMP/trial-specific) “in date” stock for current and new patients.

To record clinical trial drugs returned by the patients on appropriate drug accountability records and dispose of them according to the trial.

To assist in the ‘close-down’ and archivi

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