Overview
We are seeking a dynamic Clinical Trials Pharmacist to play a pivotal role in advancing our portfolio of innovative clinical trials. The role combines pharmaceutical and project management expertise, including overseeing the supply and storage of investigational medicinal products and ensuring the success of pharmacy participation in clinical trials.
Responsibilities
* Conduct feasibility reviews to determine if a trial can be supported by the clinical trials pharmacy.
* Present costings to sponsors for pharmacy operational expenses during the trial.
* Setup and update study‑specific documents.
* Process amendments in a 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 comply with ICH/GCP, EU Directive 2001/20/EC, FDA, GMP and the Research Governance Framework.
* Provide highly specialised professional expertise to researchers in the development of clinical trial protocols involving medication and related substances and advise on application for Clinical Trial Authorisation certification from the MHRA.
* Interact with and support Clinical Trial Technicians and Senior Technical Officer.
* Participate in all aspects of pharmacy clinical trials from set‑up to close‑down.
Qualifications
* M Pharm qualified to master’s degree level (4‑year MPharm) or equivalent.
* Registered Pharmacist with the General Pharmaceutical Council (Great Britain).
* Experience in wide hospital pharmacy settings.
* Strong problem‑identification and problem‑solving skills.
* Ability to prioritise tasks effectively.
* Good team‑working, time‑management and organisational skills.
* Excellent written and oral communication, negotiation and interpersonal skills.
* Enthusiastic, motivated and able to work within a multidisciplinary team.
* Postgraduate clinical pharmacy certificate or GPhC registered independent prescriber.
* Appropriate UK professional registration.
Desirable Criteria
* Previous clinical trials or research experience.
* Aseptic unit experience.
* Research ethics experience or training.
* Involvement in developing a service.
* Good IT skills.
* Experience in presenting to a group.
* Diploma/MSc in Clinical/Hospital Pharmacy or another appropriate research qualification.
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