Specialist Clinical Trials Pharmacist

Oxford University Hospitals NHS Foundation Trust

This job is now closed

Job summary

Hello, my name is Sergio and I am one of the Lead Pharmacists in the Clinical Trials Pharmacy department. We are a multicultural team which values diversity, inclusion, collaboration and a commitment to excellence.

We are seeking a dynamic Clinical Trials Pharmacist to play a pivotal role in advancing our portfolio of innovative clinical trials. This position offers a unique opportunity to combine pharmaceutical and project management expertise. Your responsibilities will include the updating and preparation of in-house documentation, overseeing supply, storage of investigational medicinal products, and thereby contributing to the success of pharmacy participation in clinical trials that shape the future of medicine.

You will be key in orchestrating and managing pharmacy aspects within our clinical trials. Your responsibilities will extend beyond traditional pharmacy roles, involving strategic planning, resource coordination, and project execution to ensure successful completion of clinical trials. If you are a forward-thinking pharmacist eager to integrate project management skills into your role, this is the opportunity for you.

The post will allow you to gain experience in Aseptic Preparation of the IMPs in our clinical trials aseptic unit and ATMP Unit.

Applicants not meeting the full person specification will be considered. If successful, the applicant would be appointed to a lower band until competencies for this post are achieved. All training will be provided.

Main duties of the job

Participate in all aspects of Pharmacy Clinical Trial from setup to close down. This encompasses, but is not restricted to:

Feasibility review to determine if trial can be supported by clinical trials pharmacy.
Present costings to sponsors for pharmacy operational expenses during the trial .
Setup and update study specific documents .
Process amendments in timely manner.
Proactively address challenges to ensure progression of trials, maintaining patient safety and data integrity.
Provide regular updates on pharmaceutical aspects of trials to ensure alignment with project goals.
Accuracy check oral and aseptically prepared trial medications as required.
Co-ordinate and deliver Pharmacy support to Researchers in the Oxford University Hospitals NHS Trust.
Work with the dedicated Clinical Trial Team, to plan the workload for Pharmacy Services for the Trust and ensure operational implementation.
Ensure Pharmacy procedures relating to clinical trials involving Investigational Medicinal Products are in accordance with appropriate regulations (ICH/GCP, EU Directive 2001/20/EC, FDA, GMP) and with Research Governance Framework.
Provide highly specialised professional expertise to Researchers in the development of clinical trial protocols involving medication and related substances and to provide advice & information regarding the application for Clinical Trial Authorisation certification from the MHRA.
Interact with and support Clinical Trial Technicians and Senior Technical Officer.

About us

Oxford University Hospitals NHS Foundation Trust is one of the largest NHS teaching trusts in the country. It provides a wide range of general and specialist clinical services and is a base for medical education, training and research. Clinical Research at OUH NFT is conducted to the highest standards of excellence and plays a vital role in tackling the biggest healthcare challenges of the 21st century aiming to improve the care we offer to our patients.

With a portfolio of around 1500 active clinical research studies, OUH is one of the largest and most productive research-active university hospital NHS Trusts nationally. According to a new league table of research supported by National Institute for Health Research Clinical Research Network, OUH recruited 17500 patients in 487 studies last year. Our broad research portfolio covers conditions including cancer, dementia and stroke.

In 2023 OUH opened its new facility to prepare a new range of medicines known as advanced therapy medicinal products (ATMPs), which are based on gene, tissue or cell therapy products. The new unit comes against a backdrop of rapid advances in treatments such as gene and cell therapies, monoclonal antibodies or mRNA vaccines, many of which are being investigated and developed in Oxford, especially through the Oxford BRC.

Date posted

17 April 2024

Pay scheme

Agenda for change

Band

Band 7

Salary

£43,742 to £50,056 a year per annum pro rata

Contract

Permanent

Working pattern

Full-time

Reference number

321-CORP-6164383-B7-PUB

Job locations

Churchill Hospital (cross site as needed)

Churchill Drive, Headington

Oxford

OX3 7LE

Job description

Job responsibilities

For a Detailed job description and main responsibilities please refer to the Job Description document attached

Job description

Job responsibilities

For a Detailed job description and main responsibilities please refer to the Job Description document attached

Person Specification

SL

Essential

M Pharm Qualified to masters degree level (4 year MPharm) or equivalent
Registered Pharmacist with the General Pharmaceutical Council (Great Britain)
Wide Hospital Pharmacy experience
Problem identification and solving skills
Ability to prioritise
Good team member
Good time management and well organised
Good written and oral communication skills
Good negotiation skills. Good interpersonal skills
Enthusiastic and motivated
Experience of working in a multidisciplinary team
Postgraduate clinical pharmacy certificate or GPhC registered independent prescriber.

Desirable

Diploma/MSc in Clinical/Hospital Pharmacy or appropriate Research Qualification.
Previous Clinical Trials or Research experience
Aseptic Unit experience
Research Ethics experience / training
Involvement in developing a service
Good IT skills
Experience in presenting to a group

Person Specification

SL

Essential

M Pharm Qualified to masters degree level (4 year MPharm) or equivalent
Registered Pharmacist with the General Pharmaceutical Council (Great Britain)
Wide Hospital Pharmacy experience
Problem identification and solving skills
Ability to prioritise
Good team member
Good time management and well organised
Good written and oral communication skills
Good negotiation skills. Good interpersonal skills
Enthusiastic and motivated
Experience of working in a multidisciplinary team
Postgraduate clinical pharmacy certificate or GPhC registered independent prescriber.

Desirable

Diploma/MSc in Clinical/Hospital Pharmacy or appropriate Research Qualification.
Previous Clinical Trials or Research experience
Aseptic Unit experience
Research Ethics experience / training
Involvement in developing a service
Good IT skills
Experience in presenting to a group

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).