- To facilitate the set-up, maintenance and monitoring of clinical trials.
- To prepare and update pharmacy guidelines for clinical trials, ensuring a co-ordinated approach for the smooth running of clinical trials from a pharmacy perspective.
- To build and update clinical trial oncology regimens on the electronic prescribing system Aria.
- To provide comprehensive training and support to all pharmacy staff in the accurate dispensing of clinical trials and monitor as required.
- To ensure that all essential pharmacy trial documentation is maintained in accordance with the protocol and other national and local guidelines and ensure accurate record keeping and drug accountability of clinical trials.
- To ensure effective stock control of clinical trial products and clinical trial related products.
- To order and accept receipt of clinical trial products and clinical trial related products.
- To assist in the dispensing of clinical trial products when required.
- To assist in the checking of clinical trial products when required and maintain ACPT competency.
- To provide advice and support to wider pharmacy team as required with regards to clinical trial related workload.
- To ensure all clinical trial products are stored appropriately in accordance with current legislation and study sponsors requirements. To maintain temperature monitoring records. To ensure any temperature excursions are reported and any clinical trial products affected by temperature excursions are dealt with as per local SOPs and study sponsor requirements.
- To maintain accurate and up to date expiry date records for clinical trial products and archive for future reference.
- To ensure any returns and the disposal of clinical trial products are handled in accordance with SOPs
- To prepare for and assist study sponsor representatives at monitoring visits.
- To be responsible for the closing of clinical trials and maintaining of archive records.
- To assist in maintaining and updating Clinical Trial Standard Operating Procedures (SOPs).
- To prepare invoice requisitions for clinical trial fees and monitor the receipt of income for specific trials.
- To attend GCP training as required by the Trust and to work to GCP standards at all times.
- To attend meetings regarding the set up and running of clinical trials and regularly update Lead Clinical Trial Pharmacist / Director of Pharmacy / R&I with regards to pharmacy aspects of clinical trials.
- To be familiar with procedures and activities of other internal departments within the pharmacy and their potential interactions with trial activities.
- To act as a Pharmacy point of contact for all clinical trials, for both internal and external enquiries.
- To maintain professional registration with the General Pharmaceutical Council and to undertake continuous professional development (CPD). Person Specification
- NVQ Level 3 Pharmacy Services, BTEC Pharmaceutical Sciences or equivalent
- Registered Pharmacy Technician with the General Pharmaceutical Council
- Accredited Checking Pharmacy Technician (ACPT) qualification
- GCP training
- Good understanding of Clinical Trials
- Experience of working in a hospital pharmacy
- Evidence of working in a team - Effective team player
- Good IT skills - Knowledge of Word and Excel computer systems
- Evidence of dispensing accuracy
- Evidence of supervising and mentoring others
- Evidence of aseptic preparation knowledge
- Experience of using electronic prescribing systems
- Experience of working with Clinical Trials
- Knowledge of Episys (aseptic worksheet system)
- Knowledge of Sunrise EPMA (Electronic Prescribing and Medicines Administration) system
- Knowledge of Aria (oncology electronic prescribing system)
- Experience of managing errors and risk assessments
- Experience of participating in audits / internal monitoring
- Knowledge of regulatory requirements relating to clinical trials
- Awareness of Good Manufacturing Practice (GMP) inc Annex 13 labelling requirements
- Excellent attention to detail.
- High level of initiative
- Able to problem solve
- Able to work under supervision and independently as appropriate
- Good organisational and communication (verbal and written) skills
- Good analytical skills - able to access and abstract data
- Good negotiation skills
- Good presentation skills
- Able to work under pressure and to multi task
- Basic understanding of hospital pharmacy practice
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Specialist Pharmacy Technician - Canterbury, United Kingdom - East Kent Hospitals University NHS Foundation Trust
Description
Job summary
This is an exciting opportunity for an enthusiastic and motivated individual who has clinical trials experience or relevant transferrable conjunction with our research and innovation partners we work collaboratively and proactively to offer our patients the opportunity to participate in EKHUFT Pharmacy clinical trials team are an experienced team and work hard to provide agile set-up and maintenance of clinical trials.Providing opportunities for our patients to participate in research with novel and innovative therapies is part of our future at East Kent Hospitals. An opportunity to work with brilliant and passionate professionals has arisen for a highly motivated pharmacy technician to make a difference to patients' outcomes and wellbeing.
Main duties of the job
This role is open to someone with or without clinical trial experience, who is passionate about making a difference and contributing to improving patient/carer experience.
The main duties will include facilitating the set-up, maintenance and monitoring of clinical trials that involve Investigational Medicinal Products (IMP's).
The required skills for this role include: excellent attention to detail, high level of initiative, able to problem solve, able to work under pressure and to multi-task. The role entails good organisational, communication, analytical, negotiation, presentation and IT skills.
About us
You will join a small pharmacy-based team, where you will help to ensure the standards of Good Clinical Practice (GCP) are followed and that patients who volunteer to take part in clinical trials feel valued and receive an excellent pharmacy service.
You will work closely with the Lead Clinical Trials Pharmacist, Lead Clinical Trials Pharmacy Technician, Research Delivery Teams, Principal Investigators, Research & Innovation Central Office team, Study Sponsors and wider Pharmacy and Hospital Teams.
Applications for this role should be written by the applicant. If artificial intelligence (AI) programmes are used then the application may be rejected due to this document being an important part of the assessment process. This does not prevent applicants seeking appropriate support with applications should they need to for the purposes of any declared disability.
Job descriptionJob responsibilities
Qualifications and Training
Essential
Desirable
Skills and Experience
Essential
Desirable
Governance
Essential
Desirable
Personal / Professional attributes
Essential
Desirable
