Detailed job description and main responsibilities

KEY RESPONSIBILITIES

Clinical Trials

1.       Responsible for the development of the pharmaceutical service for clinical trials by reviewing clinical trial protocols as part of study feasibility, comment on compliance with regards to:

a.       Legal, ethical and pharmaceutical viewpoint and in terms of capacity and facilities available within the pharmacy.

b.       Participation in screening, dispensing and checking of clinical trial prescriptions, and advising others of Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) and requirements relating to Investigational Medicinal Product (IMP) management

2.       To assist in efficient and set up of clinical trials, including setting up Pharmacy site files and ensuring they are well maintained and ready for MHRA inspection.

3.       Responsible for clinically screening clinical trial prescriptions and resolve identified problems with the prescriber.

4.       Ensure accurately check-dispensed medication (clinical trial and supportive care) and associated documentation (e.g. accountability logs, worksheets) is complete in a timely manner.

5.       To counsel patients on their medication in all clinical trial specialty areas.  To advise investigators, research nurses and clinical pharmacists as needed about prescribing decisions, toxicity management, treatment administration and any other clinical trial patient specific queries.  To liaise with production pharmacy and specialist clinical pharmacy teams in respect of clinical trial patients as needed

6.       Responsible for coordinating clinical trials by ensuring compliance with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) guidelines, the MHRA - Medicine for Human Use (Clinical Trials) and European Union clinical trial regulations and implement any recommendations from inspections by official bodies such as MHRA and NIHR Clinical Research Network and sponsors of trials.

7.       Support in developing and implementing policies, guidelines and procedures for the management of medicines and investigational medicinal products across the Trust.

8.       Be a primary point of contact for research delivery teams and provide specialist advice and input on all aspects of clinical trials to R&I, Investigators, and research teams.

9.       Be a primary point of contact for sponsors (commercial and non-commercial) and contract research organisations (CROs) from pre-site selection to close-out.

10.    Provide support and be a point of escalation for Clinical Trials Pharmacy Technician / practitioner staff and assistants.

11.    Review, interpret and critically review clinical trial protocols, investigator brochures, pharmacy manuals and other associated documentation incorporating further comment from appropriate specialist clinical and technical colleagues with respect to the capacity and capability assessment of the safe and effective running of clinical trials.

12.    Feedback any points of concern identified during trial review to the clinical trial pharmacy service leads, Principal Investigators, and delivery teams as appropriate, and work to identify and deliver solutions to ensure safe and effective clinical trial delivery.

13.    Awareness of Advance Gene therapies and design of trials for investigational advanced therapy medicinal products (ATMPs) and how they can be addressed.

14.    Understand the roles and responsibilities, governance and sources of support for ATMP clinical trials.

15.    Participate in the ongoing research, development, and evaluation of any new ATMPs and Genomics work streams and report findings at a local, regional, and national level.

16.    Develop and maintain capacity plans and annual reviews of Performance Indicators. Prepare reports on workload and proposals for future needs, so that they can be fed into the departmental and hospital plans.

17.    To work closely with the Clinical Trials Unit and R&I Department to negotiate with clinical trial sponsors (e.g. pharmaceutical companies, charities, academia, networks) to ensure charging is appropriate for all clinical trials and that fees are collected in a timely manner.

18.    To provide information and advice to Pharmacy Heads of Services on the potential clinical risk and cost implications of clinical trials and the impact after the trials have been completed, often when information is incomplete or lacking.

19.  To comply with legal and other requirements related to the purchase, receipt, supply, safe custody and destruction of drugs and IMP, and maintain accurate and appropriate records.