Detailed job description and main responsibilities

KEY JOB RESPONSIBILITIES

Clinical Trial 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.

3.      To manage the day-to-day running of the clinical trials service in liaison with other lead clinical trial technicians ensuring adequate staffing levels and appropriate skill mix.

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.

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 involve 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 in cancer services is calculated, requested and recorded according to standard procedures.

15.  To support the Principal Pharmacist – Research and Innovative Treatments and the Chief Pharmacy Technician – Clinical trials 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 in order 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.

Chemotherapy E-Prescribing responsibilities

19.  To work with the supplier, specialist clinical pharmacists and Chemocare Systems Manager to support the maintenance and use of the chemotherapy e-prescribing system.

20.  To review and update pharmacy chemotherapy e-prescribing procedures in liaison with the chemocare system manager; to ensure that there is a consistent approach to data input and use of the system in pharmacy.

21.  To liaise with the Specialist Clinical Trial Pharmacists, ChemoCare System manager, the ChemoCare team and the Principal Investigator to support with the build of complex clinical trial protocols on the e-prescribing system and including the generation of study specific electronic trial prescriptions.

22.   To be involved with the set-up of clinical trial SACT medications on the e-prescribing system to include validation of preparations, strengths, diluents and preparation expiries

23.  In line with protocol amendments and process ChemoCare Change Request Forms to include the alteration of existing drugs, regimens and protocols used in cancer clinical trials where necessary.

24.  To operate as a ‘super-user’ for the system.  Super-user training and status will provide a high level of access to the system to allow set-up and maintenance.

25.  To lead on the ChemoCare e-prescribing training programme for newly appointed staff, ensuring that appropriate training documentation is completed and maintained.

26.  To provide support and advice to system users, relating to clinical use of the system, as necessary.

27.  To be responsible for routine information processing from the system for department and Trust meetings, i.e. provision of data from the system for audits, including cost-saving data.

28.  To work closely with the specialist clinical pharmacists and the ChemoCare system manager regarding development of the system, to maximise benefits to the department and Trust.