Royal College Of Surgeons (Rcsi) | Pharmacist / Senior Pharmacist Crc

Job Title: Pharmacist / Senior Pharmacist CRC Department: RCSI Clinical Research Centre (CRC), Beaumont Hospital Campus.
Reporting to: CRC Director or nominee Location: RCSI Clinical Research Centre, Smurfit Building, Beaumont Hospital Contract/Duration: Permanent, Part-time (0.8 FTE) (Normally within the hours of 08.00 to 17.00 ) Remuneration: Dependent on skills and experience.
Closing Date: 10th January 2025 RCSI is a community of academic, research, clinical and professional staff working collaboratively to lead the world to better health.
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Summary of Post Appointable at either a Pharmacist / Senior Pharmacist level, we are seeking a suitable candidate to join the RCSI CRC Team at Beaumont Hospital.
Key responsibilities of the post include: The RCSI CRC is in the process of developing its pharmacy facility and services which are essential to the safe conduct of clinical trials involving investigational medicinal products (IMPs).
The CRC Pharmacy will dispense clinical trial medications in accordance with strict legislative requirements.
The Pharmacist / Senior Pharmacist will advice and make recommendations on the facilities, processes and resources required to establish the clinical trial pharmacy services in the CRC The Senior Pharmacist will undertake the provision of a range of duties to support clinical trials and research studies conducted through the CRC.
They will be responsible for routine pharmacy activities within the CRC, in compliance with Pharmaceutical Society of Ireland (PSI) regulations as applicable.
The Pharmacist / Senior Pharmacist will complete all pharmacy activities according to approved CRC Pharmacy and CRC Standard Operating Procedures (SOP's) to ensure that all studies fulfil requirements of local, national and international standards and legislation; such as EU Directives on Clinical Trials, standards of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and Good Clinical Trial Practice (GCP).
Key pharmacy services that will be provided by the CRC include: Dispensing study medications to patients.
Compounding and dispensing novel therapeutics.
Management of IMP supplies including: accountability, storage, dispensing, record keeping, destruction.
Handling patient IMP returns and monitoring compliance.
Preparation of SOP's, work instruction, prescription templates, and other applicable documents for the management of IMP at a trial site.
Maintain essential trial documents in the Pharmacy Site File and update these as required.
Specifically, the duties of the post are: The Pharmacist / Senior Pharmacist will be responsible for establishing processes and procedures for the management of IMP in the CRC.
The Pharmacist / Senior Pharmacist will be responsible for the pharmacy set-up and routine pharmacy activities of all clinical trials of IMP in the CRC.
The Pharmacist / Senior Pharmacist will: Participate in all aspects of the setting up and ongoing management of pharmacy related activities for clinical trials and research studies in the CRC.
Write, implement, maintain and adhere to procedures to ensure the safe recording, handling, storage, prescribing, dispensing, administration, dispatch and destruction of both investigational medicinal products (IMPs) and non-investigational medicinal products (nIMPs) including investigation and rectification of discrepancies.
Given the collaborative nature of our operations, these procedures to include alignment with Beaumont hospital Pharmacy Department SOP's.
Lead the CRC Dispensary Pharmacy in compliance with relevant regulations, quality initiatives and best practice procedures.
Manage the setting up and close-out of Pharmacy responsibilities for Clinical Trials and research studies in the CRC.
Manage the dispensing of IMPs and work closely with research nurses to coordinate patient dispensing visits.
Maintain pharmacy files to contain the latest study documents and correspondence.
Liaise with trial sponsor representatives and prepare pharmacy documentation for monitoring visits and follow up and action any monitoring visit findings, working closely with the Clinical Research Nurses and the Clinical Research Associates (CRAs).
Ensure that all pharmacy trial documentation adheres to the principles of GCP and CRC Quality Assurance (QA) policies and procedures.
Manage pharmacy equipment in line with pharmacy procedures.
To supervise and participate in the training of other staff in order to support the conduct of clinical trials.
Provide medicines information including delivering presentations to the CRC team if necessary.
Assist in the training and supervision of other grades of CRC staff.
Take responsibility for the delivery of education and training for all clinical trial pharmacy service staff Work collaboratively to facilitate research opportunities and support pharmacy research initiatives in the CRC Work collaboratively with other academic units to develop best practice in Clinical Trial Pharmacy Management.
Provide advice to investigators on formulation, prescribing, medication interactions and administration.
Perform temperature monitoring of all drug storage areas.
Complete aseptic compounding training and compounding tasks as deemed appropriate and necessary.
Perform stock management including stock ordering and expiry checks within the pharmacy and the CRC clinic (e.g., clinic rooms, crash trolley and anaphylaxis box).
To carry out purchasing activities as per local policy.
To assist in any metric collection and/ or audits that may be required to support the activities of the CRC To ensure the maintenance of standards of clinical hygiene within the Pharmacy.
Be responsible for regularly updating own knowledge on GCP.
Follow the CRC SOPs on reporting and implementing remedial actions for any deviations or critical incidences with pharmacy procedures or pharmacy aspects of a research protocol Comply with applicable Beaumont Hospital and RCSI policies and procedures, work safely and efficiently.
To practice in accordance with PSI standards at all times.
Highlight any discrepancies, incidents, or inadequacies in services to the CRC Director.
Undertake other duties appropriate to the post on request of the CRC Director.
Align to any hospital SOPs when working on the clinical site.
Professional development Maintain professional registration.
Undertake further education as appropriate to keep updated with changes within the field of your assigned research project/s.
Identify pharmacist research opportunities if possible.
Take responsibility for your own professional and competency development, including maintaining a record of training, continuing education and continuing professional development.
Attend and participate in: o In service and staff education o Mandatory RCSI training o Mandatory updating of required pharmacy skills o CRC staff meetings o Appropriate outside conferences and/or other professional development activities.
o Site Initiation Visits, investigator meetings and study specific training for assigned studies,) as required.
o ICH GCP Certification / recertification.
Quality Assurance Attend CRC management meetings when required.
Maintain clinical and administrative records and reporting arrangements.
Carry out all activities within the currently applicable SOPs of the CRC.
Adhere to the CRC quality management procedures.
Candidate Requirements: Mandatory Be a registered Pharmacist with the Pharmaceutical Society of Ireland (PSI), or be entitled to be so registered.
Have a minimum of five years post registration satisfactory experience.
Possess the requisite knowledge and ability (including a high standard of suitability) for the proper discharge of the duties of the office.
Evidence of organisational and project management skills.
Excellent interpersonal skills required to communicate and integrate with clinicians, clinical teams, the extended research team.
Meticulous attention to detail.
Highly motivated, with drive and initiative.
Good IT skills including Microsoft Office (particularly Word, Excel and PowerPoint) and internet and email systems.
Be willing and able to learn new skills and take on new roles as required by the position.
Desirable: Possess a post graduate Diploma/Masters in Hospital/Clinical Pharmacy or a related healthcare area or in pursuit of same.
Previous experience working as a research Pharmacist.
Experience of Aseptic Compounding.
Good Clinical Practice (GCP) training.
Experience in commercial clinical trials of medicinal products or medical devices.
Experience of working with regulatory bodies (e.g.
HPRA, EMA, FDA, MHRA).
Knowledge of, or experience in, the development of Standard Operating Procedures.
Knowledge of International Conference on Harmonisation Good Clinical Practice Guidelines.
Knowledge of the governance and legislative requirements surrounding the conduct of clinical research in Ireland.
We are all too aware that imposter syndrome and the confidence gap can sometimes stop fantastic candidates putting themselves forward, so please do submit an application - we'd love to hear from you.
Application Process Please apply online through the RCSI careers portal before the closing date with your CV and cover letter.
Informal Enquiries can be directed to Dr Fionnuala Keane, CRC Director of Operations: Please note we do not accept CVs directly.
E****mployee Benefits RCSI make sure you have the resources you need to thrive by offering a wide range of benefits in areas including time away, finance, community, health, and well-being and insuring your financial future.
Below are some additional benefits available to you as an RCSI employee: Minimum of 20 days annual leave, plus an additional 6.5 Privilege days Flexible/hybrid working options for colleagues across many roles Additional leave options incl.
paid maternity leave, paternity/parental leave, study leave 7% Employer pension contribution Onsite gym €10 per/mth incl.
classes and PT sessions Childcare support 20% discount at Giraffe Free eye test and annual flu vaccination TaxSaver commuter tickets and Bike to Work schemes A site sustainability team focusing on the environmental initiatives; Green Campus Initiative ' Competitively priced café and restaurant Equality, Diversity & Inclusion forums, and network groups Employee assistance programme with Spectrum Life Learning and Development training programmes incl.
LinkedIn Learning for career progression Discounted services incl.
GP visits, 10% off dental, staff parking, mobile tariffs, Group Scheme discount on numerous brands Sports and social club incl.
yoga, Pilates, fitness classes, Zumba, running club, social evenings, Summer BBQ Ticket Draws for events including; Rugby, Taste of Dublin, Dublin Horse Show, theatre, music & comedy events