Lead Pharmacy Technician Clinical Trials

As a registered pharmacy technician you will be part of the dedicated pharmacy clinical trials team providing a high quality and responsive service to patients, clinical staff and sponsors who use our services on the QMC/City campus.

There are currently approximately 200 studies of Investigational Medicinal Products (IMPs) which are either recruiting patients or in set up ready to begin recruitment. You will be taking the technical lead in the medicines management and set up of clinical trials at NUH.

In addition to the below summary you need to familiarise yourself with the full Job Description and Person Specification documents attached to this advert.

Main duties of the job

You must have considerable post qualification hospital pharmacy experience and experience of clinical trials would be an advantage.

Vital for this role are good written and verbal communication and interpersonal skills and you must enjoy paying close attention to detail.

Your role will be central in providing a dedicated pharmacy service for clinical trial delivery through involvement with all aspects of investigational medicines management, including assisting in the set up of new studies. The role will require development and monitoring of appropriate procedures in accordance with both Good Manufacturing Practice and Good Clinical Practice as required under Clinical Trials Legislation.

Job description

Job responsibilities

JOB SUMMARY

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 the QMC campus but will be expected to attend meetings and work at City 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 team Quality Control and the NUH Research and Innovation department, 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. With support and guidance from the Chief Technician Clinical Trials to lead on the day to day management of the clinical trials service in liaison with other Lead Clinical trial technicians.
3. To supervise and participate in the dispensing of clinical trials prescriptions and requisitions.
4. To supervise and participate in the accuracy checking of clinical trial prescriptions and nonclinical trial prescriptions where a pharmacist has previously professionally screened the prescription or where a professional screen is not required.
5. To supervise and participate in the appropriate, accurate and legible completion of Investigational Medicinal Products (IMPs) and Non Investigational Medicinal Products (NIMPs) accountability documentation.
6. 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.
7. 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.
8. With supervision and support from the Specialist Clinical Trials Pharmacist take the lead on the day-to-day management of a portfolio of clinical trials from a pharmacy perspective and ensure GCP compliance on clinical trial delivery.
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.
10. To supervise the upkeep of dedicated clinical trial storage areas, including temperature control and monitoring.
11. 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.
12. 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.
13. To have responsibility for line managing dedicated staff, to ensure these staff are inducted appropriately and complete all necessary training, host their yearly appraisal conversations, undertake sickness monitoring and performance reviews if necessary.
14. To support the Clinical Trials Finance and Admin Officer to ensure income accrued by clinical trial activity 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 host sponsors representatives when they visit the clinical trials department to perform monitoring visits, site initiation visits and close down visits for example.
19. In liaison with R& I and following clinical trial procedures oversee and support the at the end of a study with study close down and the archiving of essential trial documentation in line with national guidance.
20. To undertake a regular operational commitment in the in-patient dispensary/satellites within NUH (either at QMC or City) in order to maintain competencies and demonstrate fitness to practice as a registered pharmacy technician.

• BTEC, City and Guilds or NVQ level 3 in Pharmaceutical Services, or recognised equivalent
• Registered pharmacy technician with the General Pharmaceutical Council (GPhC)

• Existing management and organisational skills
• Qualified Accuracy Checker

• Clear understanding of the role of the technician in clinical trials management
• Extensive and varied experience of working in hospital pharmacy

• Experience in pharmacy clinical trials services

• Good verbal, written and interpersonal skills with an ability to liaise with a wide range of staff and patients within and outside NUH Trust

• Accurate and logical with excellent attention to detail
• Able to interpret complex trial protocols

• Methodical with good organisational skills and good time management
• Able to oversee more than one task at a time, prioritise accordingly and work to agreed deadlines Able to work under pressure