Specialist Clinical Trials Pharmacist

Oxford University Hospitals NHS Foundation Trust

The closing date is 17 November 2024

Job summary

Hello, my name is Irene, I am one of the Lead Pharmacists In the Clinical Trials Pharmacy department. We are excited to offer a unique opportunity for a motivated and enthusiastic pharmacist looking for a non-patient facing office-based position with no on-call cover. This is a non-clinical role, but there will be opportunities to develop clinical skills.

This role involves an emphasis on project management and meeting deadlines. You will be responsible for creating and maintaining bespoke pharmacy specific documentation for each trial you are assigned. This involves reviewing sponsor documents and collaborating with sponsors, contract research organisations (CROs) and research teams. These bespoke documents serve as instructions for anyone involved in receipting, storage, dispensing, labelling, accountability, and destruction of IMPs for the trial. A high level of attention to detail is essential as requirements of the sponsor and good clinical practice (GCP) must be met.

The post will allow you to gain experience in aseptics whilst working 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.

Whether you have previous experience with clinical trials or are looking to explore something new, we encourage you to apply. We look forward to welcoming you to our team.

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 documents .
Process amendments in timely manner.
Proactively address challenges to ensure progression of trials, maintaining patient safety and data integrity.
Provide 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 workload for Pharmacy Services for the Trust and ensure operational implementation.
Ensure that Pharmacy procedures relating to clinical trials involving (IMP's) are in accordance with appropriate regulations (ICH/GCP, Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019, EMA, 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.
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. The Trust comprises four hospitals - the John Radcliffe Hospital, Churchill Hospital and Nuffield Orthopaedic Centre in Headington and the Horton General Hospital in Banbury. For more information on OUH please view OUH At a Glance by OUHospitals - Issuu

Our values, standards and behaviours define the quality of clinical care we offer and the professional relationships we make with our patients, colleagues and the wider community.

We call this Delivering Compassionate Excellence and its focus is on our values of compassion, respect, learning, delivery, improvement and excellence.

These values put patients at the heart of what we do and underpin the quality healthcare we would like for ourselves or a member of our family. Watch how we set out to deliver compassionate excellence via the OUH YouTube channel.

Date posted

01 November 2024

Pay scheme

Agenda for change

Band

Band 7

Salary

£46,148 to £52,809 a year per annum pro rata

Contract

Fixed term

Duration

12 months

Working pattern

Full-time

Reference number

321-CORP-6730068-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
Diploma/MSc in Clinical/Hospital Pharmacy or appropriate Research Qualification

Desirable

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
Diploma/MSc in Clinical/Hospital Pharmacy or appropriate Research Qualification

Desirable

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).