Clinical Trials Assistant - Pharmacy

Job overview

The Newcastle upon Tyne Hospitals NHS Foundation Trust currently has approximately 450 on-going studies involving investigational medicinal products (IMPs) and Pharmacy has an important role in ensuring that clinical trial medications are handled safely.  An exciting opportunity has arisen for an enthusiastic and well-motivated Clinical Trials Assistant to join the Pharmacy Clinical Trials Team.  You will provide support in order to maintain a high level Trustwide Pharmacy Clinical Trials Service.

You will be required to communicate with professionals both internal and external to the Trust via telephone, e-mail and face-to-face.  You will carry out the dispensing of clinical trials prescriptions, which can be very complex and time consuming, requiring a high level of accuracy and concentration.  Other regular tasks include ordering, distribution and monitoring of storage areas (including refrigerators/ freezers) in which investigational medicinal products (IMPs) are held.

• Interview Date Wednesday 07 May 2025
• 37 Hours 30 Minutes/Week (Part time hours will be considered)
• You will be redirected to Trac to apply for the vacancy.  Please expand the job details section and read all of the information before applying for the vacancy

NO AGENCIES PLEASE

Main duties of the job

• To answer telephone enquiries from internal or external persons involved in clinical trials.
• To liaise and communicate regularly with members of other disciplines working in the Trust.
• To carry out dispensing of clinical trials prescriptions and order forms.
• To manage ordering, maintenance, distribution, destruction (where applicable) and return (where applicable) of medications used within clinical trials.
• To maintain clinical trial documentation that forms part of the Trial Master File.
• To complete and maintain in house documentation for monitoring equipment and managing clinical trials medication.
• To work in compliance with European and UK legislation related to clinical trials in particular Good Clinical Practice (GCP).
• To work in compliance with local health and safety rules to ensure a safe working environment for you, colleagues and visitors. To adhere to department and Trust Health and Safety policies (including COSHH, Risk assessments and Standard Operating Procedures) and to report any non-compliances to a senior member of staff.
• Calculates monies owed for previously agreed contracted clinical trial activities for approval by clinical trial Sponsors.
• Deals with finance queries from external organisations and Trust finance department.
• Organises and prepares invoice documentation for monies owed.

Detailed job description and main responsibilities

As well as in-house training within the Pharmacy Clinical Trials Unit, you will be required to complete a Good Clinical Practice (GCP) course (either online or face-to-face depending on availability) and subsequent refreshers courses every three years.

A base hospital/ Pharmacy Clinical Trials Unit will be allocated to the post holders on appointment.  However, you may be required to work at one of the other Pharmacy Clinical Trials Units within the Trust which include the main Pharmacy Departments at Freeman Hospital, The Royal Victoria Infirmary, The Northern Centre for Cancer Care (Freeman site) or the Campus for Ageing and Vitality (old General Hospital site).  You will report to the Specialist Senior Pharmacy Technician at the relevant site, and you will be accountable to the Clinical Trials Operations Managers, the Lead Clinical Trials Pharmacists and the Senior Lead Clinical Trials Pharmacist (all Trust-wide – see job description for more details).

Candidates must have a minimum of NVQ Level 2 in Pharmacy Services Skills or equivalent, and previous dispensing experience.  You must be able to demonstrate good oral and written communication, have basic computer skills and be capable of working with minimum supervision.

A Clinical Trials Assistant will provide technical support to clinical trials services and the wider clinical trials team with the aim of providing safe management of clinical trials patients within the hospital and community.

As a flexible working friendly organisation, we want to be sure that you can work in a way that is best for us and for our patients, and for you. Speak to us about how we might be able to accommodate a flexible working arrangement. If it works for the service, we will do our best to make it work for you.