OVERALL PURPOSE OF JOB

The position is at Advanced Specialist level, however we will also consider applications from Senior Pharmacists who may not meet the Advanced Specialist criteria but who are keen to develop their career within Clinical Trials
The purpose of this role is to lead on the provision of pharmaceutical services for Clinical Trials in accordance with the relevant ethical, governance and regulatory guidelines at Beacon Hospital, in accordance with the mission, values, vision and strategic plan of the Hospital.
The ASP will have responsibility for developing processes and business planning in relation to Pharmacy Clinical trials.
Demonstrate professional leadership within their designated clinical area through effective communication with other clinical practitioners, motivation of staff and challenging barriers to change.

KEY RESPONSIBILITIES AND DELIVERABLES

The Advanced Specialist Pharmacist practices to a high level of capability across six domains of advanced practice aligned with International Pharmaceutical Federation (FIP) Advanced Level II in the specialist area of practice.
The six domains of advanced practice are defined as follows:
Expert Professional Knowledge
Working with Others
Leadership
Management
Education, Training and Development
Research and Evaluation
Take responsibility for professional leadership for Clinical trials by liaising with Head of Pharmacy Services, Head of Pharmacy Cancer Services amongst others.
Expert Professional Knowledge
To ensure medicines are used appropriately, safely and cost effectively in accordance with Hospital policies, standard operating procedures and relevant legislation.
To provide an effective, efficient and safe pharmaceutical service for patients participating in Clinical Trials in accordance with legal requirements, accepted professional and ethical standards and agreed local policies & procedures particularly the requirements of Good Clinical Practice (GCP).
To be responsible for the safe introduction of new cancer Clinical trials into the Pharmacy department ensuring that all SOPs are in place and followed with the completion of all required documentation.
To be responsible for and partake in the development of procedures to ensure the safe recording, handling, storage, prescribing, dispensing, administration, dispatch and destruction of investigational medicinal products including investigation and rectification of discrepancies.
Ensure that all pharmacy trial documentation complies with the EU clinical trials regulations, adhering to the principles of GCP and Quality Assurance (QA) policies and procedures.
Contribute to pharmaceutical initiatives to ensure the optimisation of patient safety initiatives including those which help with the seamless transfer of patients between different healthcare settings.
Be cognisant of and advise appropriately of regulations (Medicinal Products, Prescription and Control of Supply and Misuse of Drugs Regulations), as applicable to Clinical Trials.
Working with others
Act as a professional resource within their area of specialisation for advising other pharmacists and other healthcare professionals in the organisation.
Provide advice to investigators on formulation, prescribing, medication interactions and administration.
Ensure that amendments to the clinical trial, that involve the IMP and/or other medicines are reflected in the pharmacy documentation, by updating procedures and the file to include the latest protocols and documents.
Liaise with the HPRA, and other such regulatory authorities and groups as may be required.
Prepare pharmacy documentation for HPRA GCP inspections and the follow up and action of GCP inspection findings.
To engage and liaise with CRAs and study sponsor team to ensure all requirements are met.
To be responsible for ongoing cancer clinical trials ensuring compliance with GCP until trial close down.
Leadership
To participate in Policy and SOP development and implementation within the Pharmacy department and Clinical Trials Office.
To ensure that a Pharmacy Clinical Trial fees agreement is produced where appropriate
To review and assess Cancer Clinical Trial Protocols for current and future financial implications and resource requirements to the Hospital.
Management
Ensure the safe use of medicines by evaluating and managing risks associated with the use of medicines and by participating in the hospital’s Medicines Safety reporting process.
Manage and professionally supervise other pharmacy staff assigned to Clinical Trials.
Continually monitor the service to ensure it reflects current needs.
Optimise the potential of pharmacy resources, skills and knowledge through monitoring and evaluation, underpinned by research and professional development within their area of speciality.
Actively participate in risk management issues, identify risks and take responsibility for appropriate action.
Report and manage any adverse incidents in accordance with organisational guidelines.
Under the direction of their line manager, investigate critical incidents within their designated areas of responsibility and work with the multidisciplinary team to identify and implement preventative and corrective solutions in order to improve patient care.
Be aware of, contribute to, and implement agreed policies, procedures and safe professional practice by adhering to relevant legislation, regulations and standards.
Participate in individual performance review.
Maintain records according to local and statutory requirements.
Participate in continuing education and research activities consistent with the post. Ensure best practice and compliance with agreed clinical guidelines.
Ensure that all departmental and hospital wide Health and Safety protocols and procedures are adhered to and all areas of non-compliance are promptly addressed.
Performance of such other duties appropriate to the post, including on call and the participation in extended opening rosters including weekend opening and other such services that may from time to time be introduced by the Head of Pharmacy Services