Aseptic Clinical Trials Administrator

Job Overview

University Hospital Southampton NHS Foundation Trust is delighted to offer a fantastic opportunity to work with us.

Please see below for a detailed job description of the role.

Open only to applicants from Hampshire & Isle of Wight NHS Integrated Care System, which is limited to:

Hampshire and Isle of Wight ICB, Portsmouth Hospitals University NHS Trust, Isle of Wight NHS Trust, University Hospital Southampton FT, Hampshire and Isle of Wight Healthcare NHS FT, South Central Ambulance Service, or Hampshire Hospitals FT.

Your main responsibilities will be accurate aseptic preparation of sterile medicinal products; including chemotherapy and advance medicinal products, according to study protocol and Clinical Trials written methods, as well as dispense bought in medicinal products ready for final release. Take responsibility for the completion of daily documentation (which includes start and end of day task sheets and recording room and isolator pressure sheets) and Clinical Trials records (forms/logs and drug accountability), creating worksheets.

For an overview of the main duties and to understand the day-to-day responsibilities in more detail, please see the Job Description and Additional Information Sheet documents also attached.

This role will also involve a weekend working commitment in the aseptic units, which would be half a day every 6 weeks

Main duties of the job

Attached you will find the person specification document which provides more detail about the essential and desirable skills and experience needed for this role. We highly recommend you review this document and use it when completing your application as these criteria are used by hiring managers as guidance during shortlisting.

For an overview of the main duties of the role please see the ‘Job Description and Main Responsibilities’ section below. To understand the day-to-day responsibilities in more detail please read the full job description document attached.

Working for our organisation

As one of the largest acute teaching Trusts in England, we offer learning and development opportunities to help you achieve the career you aspire to.

All non-clinical roles may involve a mixture of on site and remote working, Specific details and flexible working options can be discussed as part of the interview process. UHS employees are able to access a range of NHS discounts, are entitled to a minimum of 35 days paid holiday (pro rata), and we offer a generous pension scheme.

Southampton is an attractive place to live and work situated on the south coast, with an international airport and direct trains to London. The New Forest National Park and beaches of the Jurassic coast are also right on our doorstep. The city offers living costs 20% lower than London and 14 schools rated outstanding by Ofsted.

This is an exciting opportunity to be at the forefront of medicines innovation and development, by playing a part in research that will shape the future of medical treatments. UHS hosts a large variety of studies, including novel cell therapies and phase 1 trials, for various specialities such as cancer, neurology, ophthalmology, and haematology.

You would work within the clinical trials aseptic pharmacy team and alongside research teams to ensure the safe and efficient delivery of aseptic investigational medicinal products (IMPs) in compliance with regulatory standards and protocols.

Detailed Job Description And Main Responsibilities

You will need knowledge of Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP), great attention to detail, time management and team work skills.

There will be an opportunity Undertake the ‘Pre and In Process’ checking (PIPC) qualification and complete associated competencies required for sign off.

Attached you will find the job description and person specification and additional information sheet, which provides more detail about the essential and desirable skills and experience needed for this role. We highly recommend you review these documents and use them when completing your application.