Job Description Job Title: Advanced Specialist Pharmacist Clinical Trials Department: Pharmacy Reports to: Head of Pharmacy Services, Head of Pharmacy Cancer Service Date: 2025 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 hospitals 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 Specialised Area Service: To be responsible for the safe and effective operation of the Clinical Trial service.
Quality Ensure that their Specialised pharmacy service is analysed and optimised by undertaking regular clinical/technical audits in relation usage and capacity.
Participate in JCI Accreditation and adherence to standards and hospital-wide quality management programmes.
Use accurate data to demonstrate activity and report medication events.
Carry-out risk assessments and effect change in a timely manner, where patient safety could be compromised.
Contribute to hospital wide quality reports Lead the process of developing protocols and guidelines designed to deliver optimal and economical patient care.
Report all medication incidents in a timely fashion, via the approved reporting system and participates in any remedial actions that are designated the responsibility of the pharmacy department.
Training and Development Participates in in-service training and continuing education programmes within the department Undertake continuous professional development and develop professional knowledge and competencies.
Identify own training needs and provide evidence of maintaining and updating specialist and general pharmacy knowledge.
Participate in mandatory training programmes.
Develop, support and assist in the training of pharmacists, pharmacy technicians and pharmacy students in their area of speciality as appropriate.
Develop and/or deliver teaching sessions for NCHDs, nurses and/ or HSCPs in relation to medication in their area of speciality.
Participate in education and training in an external environment as required by the Head of Pharmacy Services This may include having teaching responsibility in universities.
Lead and Contribute to audit and quality improvement initiatives.
Actively promote the implementation of evidence-based practice within the area of speciality and/or organisation.
Collaborate with the multidisciplinary team to contribute to research and its application within the area of speciality and/or organisation.
Presentation of research or evaluation findings at research or professional symposium.
Flexibility The above indicates the main duties of the post, which may be reviewed in the light of experience and developments within the service.
This post requires a high level of flexibility to ensure the delivery of an effective and efficient service.
Therefore, the post holder will be required to demonstrate flexibility as and when required by their manager.
Person Specification Qualifications Essential: Be registered with the Pharmaceutical Society of Ireland.
Diploma/MSc in pharmacy practice (clinical).
Desirable: Further Qualification such as a Diploma or M.Sc.
in Clinical Pharmacy, Business, Risk Management, Managerial qualification etc.
Experience Essential: 4 years post registration hospital experience, of which at least 2 years must be in the relevant specialty demonstrating the required level of specialist practice Excellent working knowledge of: - Pharmacy training and education issues - Managing, supervising and training staff - Clinical Pharmacy - Financial control, including financial reporting on drug usage and drug consumption - Change management and change processes - Risk management and medication safety - Experience of hospital interdisciplinary committees, including actioning outcomes - Service management experience Desirable: Experience of interdisciplinary team management in the hospital environment.
Experience of Project management Skills & Abilities Essential: Ability to plan, manage and implement pharmacy projects.
Can prioritise workload.
Collaborate with Pharmacy management and other hospital departments to ensure delivery of an effective pharmacy service.
Monitor and maintain health, safety and security of self and others Train and lead team of skilled staff Create, promote and maintain open communications and healthy working relationships Desirable: Experience in the process of developing protocols and guidelines Experience in training and leading a team of skilled staff.
Personal Competencies Is self-motivated and committed towards quality service provision.
Can motivate others.
Excellent oral and written communication skills.
Has an inherent person-centred philosophy which is respectful and assertive towards clients, staff and other contacts.
Enjoys working as part of a team.
Is honest and trustworthy.
Is accurate.
Is computer literate.
Skills: phrmacist specialist pharmacist advances specialist pharmacist