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CLINICAL TRIALS DUTIES

1. To provide effective communication within pharmacy department and with the R&D department, the research team, multidisciplinary team and various UK organisations and pharmaceutical companies.
2. To assist the Pharmacy Clinical Trials Manager in management of the pharmacy aspects of clinical trials of Investigational Medicinal Products (CTIMPs) at University Hospitals Plymouth NHS Trust to include initial trial set up.

3. To assist Pharmacy Clinical Trials Manager and liaise with R&D finance team to invoice sponsors appropriately

4. To assist Pharmacy Clinical Trials Manager and to provide costs of medication to R&D finance team for clinical trial agreements and model agreement for non-commercial research

5. To participate in feasibility assessment of potential CTIMPs

6. To undertake general dispensing 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 patients and carers, counselling as appropriate, including giving sensitive information on drug therapies.

7. To perform a final accuracy check on items dispensed by other members of the trial team.

8. To coordinate and ensure medications are ready according to priorities e.g. clinical urgency and time of appointment

9. In collaboration with the pharmacy clinical trials team and research team to ensure accurate record keeping of drug accountability of all clinical trials (both written and computer records). To investigate and document any discrepancies, and report to the appropriate sponsor’s representative.

10. 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.

11. To participate in the ordering and receipt of clinical trials products following trial protocols, study specific instructions and the departmental SOPs.

12. To monitor appropriate storage of all clinical trial products (including clinical trial products stored outside of pharmacy) ensuring storage condition records and accurate expiry records for all clinical trial products are kept up to date and archived for future reference according to GCP and GMP Guidelines.

13. To process amendments to clinical trials e.g. updated pharmacy manuals, promptly and accurately ensuring that trial specific guides and dose preparation worksheets are updated following review and new procedures put in place if applicable.
14. To be responsible for the return and subsequent storage and reconciliation of Clinical trials IMP in line with the relevant pharmacy clinical trial SOPs relating to efficient stock control, issue and return or safe disposal of drugs relating to clinical trial IMP.

15. To supervise the study trial monitoring and study close out visits ensuring that both the pharmacy site files and drug returns are prepared in advance. Also ensuring the completion of any and all follow up actions.

16. To respond quickly and appropriately to all enquiries and queries, directing to most appropriate team member.

17. To carry out archiving of clinical trial documentation and the retrieval of archived documents, if required, ensuring all patient-identifiable data, generated as a result of trials are archived in accordance with clinical trials guidance and legislation.

18. Assist in investigating, reporting and recording of errors and near-misses where appropriate and to prioritise effectively.

19. To assist in the supervision, training and appraisals of the trial STO, ATOs and SATOs.

20. To ensure all staff use pharmacy computer systems correctly in relation to Clinical Trials, that data is entered accurately from prescription forms or any other documentation used in the supply of Clinical Trial IMP and that data is stored and archived appropriately in accordance with local and regionally agreed guidelines.

21. To ensure that all trials are run in accordance with GCP, Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) guidelines/department procedures reporting any deviations to the Pharmacy Clinical Trials Manager.

22. To ensure that pharmacy equipment is kept in a clean and usable condition.

23. To attend GCP training/sessions as appropriate and to work to GCP at all times.

24. To participate in the appraisal process and to undertake appropriate mandatory training.
25. Support and participate in the Sponsor led audits and undertaking of internal audits, and assist in the implementation of any necessary action following the audit recommendations.

26. Assist with preparation for inspection by the MHRA, FDA, CQC and other regulatory bodies as required

27. To attend the clinical trials team meeting and other meetings as required.

28. To contribute and assist with advice to pharmacy staff about clinical trials.
29. To be able to adhere to Standard Operational Procedures and policies without supervision.

30. To participate and maintain a record of continuing personal and professional development.

PRODUCTION SERVICES DUTIES

1.     1. To oversee, and as required to coordinate, the management of clinical trials prepared in the Pharmacy Production Services to ensure all drug products are prepared to a high standard as set out in study specific documents, standard operating procedures and appropriate guidelines.

2. To prepare the first draft of master product documentation for new products and the first draft of new standard operating procedures under the direction of the Pharmacy Clinical Trial Manager or Advanced Specialist Pharmacist Clinical Trials.

3. To assist with stock control including the production and checking of routine stock checks and ensuring stock rotation and expiry date checks.