Detailed job description and main responsibilities

To take the lead in co-ordinating the technical aspects of clinical trial activities in clinical trials, ensuring compliance with standards of clinical trial management as outlined in NUH Trust Clinical Trials Policy, Guidelines for the Safe and Secure Handling of Medicines, relevant and applicable EU and UK legislation and the Research Governance Framework for Health and Social Care 2005.

The post holder will be based primarily at City campus but will be expected to attend meetings and work at QMC Campus to enhance the effectiveness of this role as appropriate.

KEY JOB RESPONSIBILITIES

1.      In conjunction with the Pharmacy Clinical Trial team (including specialist technicians and pharmacists), the Production Department Management team and Quality Control staff, assist in the delivery of a responsive clinical trials service, to ensure good clinical practice standards (GCP) and the needs of service users are met.

2.      To support the Specialist Clinical Trials Pharmacists and Chief Pharmacy Technician – Clinical Trials by managing the clinical trials,  technical and support  staff, through liaison with the lead trial technicians in cancer and non-cancer services, other senior technicians and pharmacists, to ensure adequate staffing levels and appropriate skill mix.

3.      To manage the day-to-day running of the clinical trials service in liaison with other lead clinical trial technicians.

4.      To supervise and participate in the dispensing of clinical trials prescriptions and requisitions.

5.      To supervise and participate in the accuracy checking by pharmacy technicians of all dispensing where a pharmacist has previously professionally checked the prescription or where the professional check is not required.

6.      To supervise and participate in the appropriate, accurate and legible completion of Investigational Medicinal Products (IMPs) and Non Investigational Medicinal Products (NIMPs) accountability documentation.

7.      To review and update clinical trial documentation and procedures in liaison with the Production Department Management team, the Pharmacy Clinical Trial team and the Quality Control Department to ensure a consistent approach.

8.      To assist the clinical trials pharmacists in the review and set-up of new clinical trials; review of amendments and updates to existing studies and dissemination to all relevant pharmacy staff to ensure compliance with protocols and procedures in line with GCP. Involving close working with Sponsor representatives on how research can be delivered within the Trust. This will include writing study specific dispensing procedures, liaison with the Production Management team, research staff and liaison with the ChemoCare team (where necessary).

9.      Alongside Specialist Pharmacist lead on allocated clinical trials from a pharmacy perspective and ensure GCP compliance on clinical trial delivery.

10. To manage stock control of trial medicines in liaison with the Pharmacy Clinical Trial team, including ordering and receipt, monitoring of stock levels, reconciliation of returns, monitoring of expiry dates, investigation and rectification of discrepancies in accountability and ensuring appropriate storage conditions. To lead in ensuring that correct trials medication is available for manufacture in the chemotherapy production unit in a timely manner, as required and that other associated medicines are ordered. 

11. To supervise the upkeep of dedicated clinical trial storage areas, including temperature control and monitoring.

12. To measure and monitor all aspects of the clinical trial service on a regular basis liaising with the Information Technology and Finance administrators as needed.

13. To assist in the induction and training of new pharmacy staff in clinical trial services and where necessary, nursing and medical research staff to ensure compliance with clinical trials protocols and procedures.

14. To ensure income accrued by protocols is calculated, requested and recorded according to standard procedures.

15. To support the Principal Pharmacist – Research and Innovative Treatments and the Advanced Pharmacy Technician – Research and Innovation in preparation for and during clinical trial audit by Sponsors and MHRA inspections

16. To undertake project work, e.g. review of service or standards, as required providing data with which to develop the service or/and implement change as appropriate.

17. To liaise with teams within pharmacy, the NUH Trust Research and Innovation Directorate and other NHS Trusts, and trial investigators, their research delivery team representing a sponsoring organisation or personnel from national and local clinical research networks, when necessary and appropriate.

18. To undertake a regular operational commitment to maintain competencies and demonstrate fitness to practice as a registered pharmacy technician, which may include dispensing, (including cytotoxic and controlled drugs), counselling patients on their    medication, accuracy checking (including controlled drugs) and utilisation of the pharmacy computer system.

19.  To participate as an appraiser and appraisee in the departmental individual professional development review, supporting and working towards identified objectives and training requirements in order to maintain and continuously develop performance for the benefits of service and patient care.

20. To participate in weekend and bank holiday working as required, in  accordance with departmental rotas, in order to fulfil contractual obligations

21. To participate in the interviewing and selection of staff for the Clinical Trials Pharmacy department.

22.  To adhere to all relevant legislation, such as the Medicines Act, GMP, GLP, GCP, H&S, COSHH, European Directive 2001/20/EC etc. and to Trust policies.

23. To be accountable for own professional practice at all times, in accordance with the Code of Ethics of the Royal Pharmaceutical Society of Great Britain.

24. To maintain confidentiality in all work areas.

25. To undertake annual mandatory training e.g. manual handling, fire, security, basic life support etc.

26. To undertake any other duties that may reasonably be required as agreed with senior staff.