Lead Technician Pharmacy Clinical Trials

JOB SUMMARY

To provide the technical lead in the provision of pharmacy services in trials of Investigational Medicinal Products, with particular responsibility for paediatric oncology and haematology protocols, 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 QMC campus but will be expected to attend meetings and work on the City Campus to enhance the effectiveness of this role and in accordance with service needs 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, to assist in the delivery of a responsive clinical trials service, setting up and managing appropriate processes to ensure that the needs of service users are met.

2.To supervise the work of clinical trials support staff in providing high quality services

3.To support the development of clinical and technical services provided by the clinical trials satellite, with particular responsibility for paediatric oncology and haematology protocols.

4.To support the Clinical Trials Co-ordinator by managing the clinical trials support staff and when necessary to liaise with other senior technicians and pharmacists to ensure adequate staffing levels and appropriate skill mix.

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

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

7.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.

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

9.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.

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

11.To support the clinical trials co-ordinator in the regular development, writing, monitoring, reviewing and up-date of clinical trials procedures and documentation to disseminate to all relevant pharmacy personnel and where necessary nursing and medical research staff to ensure compliance with protocols and procedures.

12.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. This will include writing study specific dispensing procedures, liaison with the Production Management team, research staff and liaison with the ChemoCare team to ensure the timely set up of cancer trial protocols on the ChemoCare system.

13.To liaise with clinical pharmacists, manufacturing, QC, procurement colleagues and the Research and Innovation Directorate within NUH Trust and other NHS Trusts, and trial investigators, their support staff, clinical research staff representing a sponsoring organisation or personnel from national and local clinical research networks, when necessary and appropriate.

14.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.

15.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.

16.To ensure income accrued by the clinical trials service is calculated, requested and recorded according to standard procedures.

17.To support the Pharmacy Clinical Trials Co-ordinator in preparation for and during clinical trial audit by sponsors and MHRA inspections

18.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.

19.To support the operation of the paediatric ALL (Acute Lymphoblastic Leukaemia) clinic. This will include:

• Regularly dispensing and checking of medication for the ALL clinic and providing patient/ parent counselling as required.

• Being familiar with relevant protocols in Paediatric Oncology involving oral chemotherapy.

• Ensuring an adequate number of staff are trained to dispense oral chemotherapy including in the ALL clinic

20.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 controlled drugs and cytotoxics), counselling patients on their medication, accuracy checking (including controlled drugs) and utilisation of the pharmacy computer system.

General

1.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.

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

3.To participate in the interviewing and selection of staff for the Pharmacy department.

4.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.

5.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.

6.To maintain confidentiality in all work areas.

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

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

This job description is not exhaustive. It is intended to give an outline of what is expected and is subject to annual review as part of the departmental IPCR scheme.