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Specialist Research Clinical Trials Pharmacist

Specialist Research Clinical Trials Pharmacist

NHSPortsmouth, England, United Kingdom
17 days ago
Job description

Specialist Research Clinical Trials Pharmacist

Portsmouth Hospitals University NHS Trust

Full time : 37.5 hours per week

Permanent contract

An exciting opportunity has become available within Pharmacy's Clinical Trials department for an ambitious and driven Pharmacist. You will be working with a specialist team of Pharmacists and Pharmacy Technicians who are dedicated to delivering on Clinical Trials Research. You will receive support and every opportunity to grow and develop within this role.

The role will include providing pharmaceutical advice and support development of the clinical trials pharmacy service, in order to optimise patient benefit from treatment with medicines and ensure the safe, efficacious, and cost-effective use of medicines.

Main duties of the job

  • To assist the Pharmacy Clinical Trials Manager in all aspects of clinical trials and ensure compliance with current national guidance, the International Conference of Harmonisation Good Clinical Practice (ICH GCP) guidance and the Research Governance framework (2005).
  • To support the Trust vision for clinical research delivery and the provision of a quality pharmaceutical service to the Research & Innovation (R&I) team and trial participants.

Job responsibilities

General

  • Deliver and coordinate pharmacy support to the Research & Innovation team at Portsmouth Hospitals University NHS Trust.
  • Work within the pharmacy clinical trial team to enable the delivery of the Trust research strategy ensuring operational implementation is in line with local key performance initiatives and the R&I project planning schedule.
  • Ensure that pharmacy procedures relating to clinical trials involving Investigational Medicinal Products (IMPs) are in accordance with appropriate national and international legislation (ICH / GCP, EU directive 2001 / 20 / EC, GMP) Research Governance Framework (2005).
  • Provide highly specialised professional expertise to the PHU research team in the development of clinical trial protocols involving medication regarding the application for Clinical Trial Authorisation (CTA) certification from the MHRA.
  • Deputise for the Lead Pharmacist for Clinical Trials at key research meetings.
  • Support the Lead Clinical Trial Pharmacy Technician and Pharmacy Clinical Trial Assistant.

    • Standards in Clinical Research

  • Ensure compliance with relevant standards for the operation and management of clinical trials.
  • Advise and support researchers in complexities and feasibility of clinical trial design and logistical delivery of Clinical Trials for Investigation Medicinal Products (IMPs) including risk assessment and stakeholder engagement.
  • Train medical nursing and pharmacy staff in all aspects of handling drugs in clinical trials.
  • Liaise with other centres for clinical research to ensure common standards of practice.
  • Develop and maintain expertise and knowledge in all aspects of the use of medicines in research.
  • Keep up to date with legislation relating to the conduct of clinical trials involving IMPs.
  • Assist in the development of Pharmacy policies and procedures to support the delivery of clinical trials involving medication and related substances.
  • Implement and review written pharmacy guidance and SOP's in liaison with pharmacy colleagues to ensure local engagement and uptake.
  • Help maintain and update the clinical trials database on Trust activity.
  • Supervise sponsor approved pack down arrangements for IMP with previously approved batch record documentation and labels (primary and secondary) in accordance with GMP.

    • Support to individual Clinical Trials

  • Set up the specific study file with all necessary essential documentation, in preparation for supervised pharmacy sign off and eventually independent pharmacy sign off.
  • Coordinate shipment and receipt of investigational medicinal product (IMP) in line with Clinical Trial SOP's and ensure compliance with Good Manufacturing Practice legislation.
  • Support the clinical trials pharmacy technicians as required in multidisciplinary team meetings with investigators to initiate, manage and close down trials hence ensuring pharmacy participation.
  • Adhere to correct quarantine / disposal procedures for trial medications.
  • Liaise with the specialist clinical pharmacists when assessing, approving, or initiating new projects, and update dispensary leads on newly set up studies.
  • Act as a source of Research expertise to advise on complex issues such as trial design, procurement, randomisation, blinding, and documentation for in-house clinical trials and defend the opinions or decisions if the advice is challenged.
  • Provide cost quotations for pharmacy activity in clinical trials following review of the protocol.

    • Clinical Practice Role

  • Where necessary provide a ward-based clinical pharmacy service according to Trust agreed standards including :
  • Individual Prescription review to optimise therapy.
  • Confirmation of the patient's medication history.
  • Advise on dosage, side effects, cautions and monitoring required.
  • Advise on administration of medicines.
  • Appropriate and clear endorsing of prescriptions to ensure safe practice.
  • Monitor the effect and appropriateness of medication.
  • Education of patients on their medications.
  • Ensure medicines are used appropriately, safely and cost effectively in accordance with Trust policy, standard operating procedures and medicines legislation.
  • Monitor medicine use within the ward area. This includes recording of significant clinical interventions and risk management :
  • Participation in investigating clinical incidents
  • Recording significant clinical incidents / near misses
  • Ensuring compliance with medicines legislation and local policies
  • Use available information to influence prescribers and ensure the most cost-effective choice of therapy.
  • With the rest of the members of the clinical pharmacy team, support the strategic developments of the service e.g. electronic prescribing, discharge process improvements etc.
  • Supervise, train and support new members of staff.
  • Participation in weekend and bank holiday working according to the rota.

    • Professional Role

  • Participate in Continuous Professional Development.
  • To be professionally accountable for actions and advice.
  • To ensure confidentiality is maintained at all times.
  • To be aware of training and competency assessment of pre-registration pharmacist trainees, diploma pharmacists and student pharmacy technicians and to participate in their training and competency assessment as required.
  • To support inpatient / outpatient dispensary cover according to the rota.
  • Participation in weekend and bank holiday working according to the rota.
  • To attend clinical trial specific training courses and maintain up to date knowledge including web-based learning.
  • Any other reasonable duties as requested by the Chief Pharmacist.

    • Person Specification

    Qualifications

  • Master or Bachelor's Degree in Pharmacy
  • Member of General Pharmaceutical Council
  • Completed or studying for diploma in Clinical Pharmacy or equivalent
  • Non-medical prescribing

    • Experience

  • Good understanding of the role of a hospital pharmacist, gained through demonstrable experience of working in a UK hospital pharmacy
  • Clinical experience in a range of clinical specialities
  • Excellent knowledge of general clinical pharmacy and drug use
  • Previous experience of teaching, training and staff development
  • Experience of developing pharmacy services
  • Previous experience in clinical trials / research
  • Previous experience of EPMA
  • Previous experience of EDGE

    • Skills and Knowledge

  • Good interpersonal skills
  • Good communication skills, written and verbal, with ability to demonstrate fluency, clarity and effectiveness at all levels
  • Demonstrable confidence as a clinical pharmacist
  • Demonstrable ability to work in a team
  • Demonstrable ability to motivate self and others
  • Demonstrable ability to organise and manage workload
  • Demonstrable ability to use initiative
  • Demonstrable ability to maintain quality standards
  • Sound knowledge of therapeutics across all clinical specialties
  • Clinical appraisal skills
  • Word and data processing ability
  • Analytical skills
  • Understanding of NHS priorities
  • Good understanding of clinical research process including good clinical practice (GCP)
  • Experience of working in clinical trials
  • Good knowledge of "A Guide to good manufacturing practice and Aseptic Dispensing for NHS patients".
  • Clinical appraisal skills and experience of writing research publications in scientific and pharmaceutical journals

    • 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.

    Portsmouth Hospitals University NHS Trust

    J-18808-Ljbffr

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    Clinical Pharmacist • Portsmouth, England, United Kingdom