Lead Pharmacy Technician Clinical Trials

Job description

Job 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.

Person Specification

Training and Qualifications

Essential

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

Desirable

• Existing management and organisational skills
• Qualified Accuracy Checker

Experience

Essential

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

Desirable

• Experience in pharmacy clinical trials services

Communication and relationship skills

Essential

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

Analytical and Judgement skills

Essential

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

Planning and organisation skills

Essential

• 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

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

UK Registration

Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).

Employer details

Employer name

Nottingham University Hospitals NHS Trusts

Address

City Campus

Hucknall Road

Nottingham

NG5 1PB

Employer's website

https://www.nuh.nhs.uk/ (Opens in a new tab)