The Advanced Specialist Pharmacist plays a crucial role in leading the provision of pharmaceutical services for Clinical Trials at Beacon Hospital. This position involves developing processes and business planning in relation to Pharmacy Clinical trials, while ensuring compliance with relevant ethical, governance, and regulatory guidelines.
Key Responsibilities
* 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, adhering to legal requirements, accepted professional and ethical standards, and agreed local policies & procedures, particularly those of Good Clinical Practice (GCP).
* To be responsible for the safe introduction of new cancer Clinical trials into the Pharmacy department, ensuring that all Standard Operating Procedures (SOPs) are in place and followed, along with the completion of all required documentation.
The Advanced Specialist Pharmacist will also:
* Contribute to pharmaceutical initiatives to optimize patient safety, including seamless transfer of patients between healthcare settings.
* Advise investigators on formulation, prescribing, medication interactions, and administration.
* Liaise with the Health Products Regulatory Authority (HPRA), other regulatory authorities, and groups as may be required.
* Prepare pharmacy documentation for HPRA GCP inspections and follow up on inspection findings.
* Engage and liaise with Contract Research Associates (CRAs) and study sponsor teams to ensure all requirements are met.
* Be responsible for ongoing cancer clinical trials until trial close-down, ensuring compliance with GCP.
Leadership and Management
* To participate in Policy and SOP development and implementation within the Pharmacy department and Clinical Trials Office.
* To review and assess Cancer Clinical Trial Protocols for current and future financial implications and resource requirements to the Hospital.
* To manage and professionally supervise other pharmacy staff assigned to Clinical Trials.
The successful candidate will have excellent working knowledge of pharmacy training and education issues, managing, supervising, and training staff, clinical pharmacy, financial control, change management, risk management, and medication safety. They will also possess strong leadership and management skills, with the ability to prioritize workload, collaborate with pharmacy management and other hospital departments, and train and lead a team of skilled staff.
Education and Qualifications
A registered pharmacist with a Diploma/MSc in pharmacy practice (clinical) is essential. Further qualifications such as a Diploma or M.Sc. in Clinical Pharmacy, Business, Risk Management, or Managerial qualification are desirable. A minimum of 4 years post-registration hospital experience, with at least 2 years in the relevant specialty, is also required.