Specialist Pharmacy Technician - Clinical Trials

Job description

Job responsibilities

• 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

Qualifications and Training

• 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

Skills and Experience

• 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)

Governance

• 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

Personal / Professional attributes

• 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

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website.

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants.

UK Registration

Applicants must have current UK professional registration. For further information please see NHS Careers website.

Employer details

Employer name

East Kent Hospitals University NHS Foundation Trust

Address

Kent & Canterbury Hospital

Canterbury

CT1 3NG

https://www.ekhuft.nhs.uk/patients-and-visitors/