Specialist Clinical Trials Pharmacist

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.

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

Employer details

Employer name

Oxford University Hospitals NHS Foundation Trust

Address

Churchill Hospital (cross site as needed)

Churchill Drive, Headington

Oxford

OX3 7LE

Any attachments will be accessible after you click to apply.

321-CORP-6730068-B7-PUB