Clinical Trials Pharmacy Assistant - London, United Kingdom - Clerkenwell Health
Description
Job Description
Reports to: Lead Clinical Trial Pharmacist and Home Office Compliance Officer
Main duties:
Support the day-to-day running (set-up and maintenance) of trials within pharmacy at Clerkenwell Health
Dispense and/or aseptically-prepare clinical trial doses for various formulations: oral, inhalation, intravenous etc.
Support the preparation (and updating as necessary) of pharmacy files for each trial, to enable pharmacy staff to dispense clinical trials efficiently and accurately.
Undertake tasks such as correct receipt, storage, destruction and return of clinical trial drugs, following Sponsor guidance and ensuring that the correct documentation is provided prior to the use of the received drug and that documentation is completed appropriately in accordance with Good Clinical Practice (GCP)
Ensure that all pharmacy clinical trial documentation including correspondence, dispensing records and prescriptions are filed in the appropriate clinical trial files and that they are kept up-to-date.
To ensure the correct storage of all clinical trial products in areas designated and labelled for clinical trial drug storage.
To ensure that company is complying with the requirement of the Home Office license for controlled drugs and to aid completion of annual renewal process.
Assist the Lead Clinical Trial Pharmacist in preparing documents needed for Home Office license application.
Assist in the creation of internal pharmacy templates/logs, drug accountability records and other documents required for clinical trials as directed.
To assist in the writing of standard dispensing procedures for each clinical trial requiring dispensing of clinical trial drugs.
To monitor Logicall temperature monitoring system and document necessary info per study relevant document
Support the close down and regular archiving of clinical trials.
Support the audit process for clinical trials at site helping to resolve any outstanding actions in a timely fashion.
Maintain up to date GCP training
Liaise with study sponsor representatives as appropriate
To attend clinical trial visits (PSSVs, SIVs etc) and support drug company CRA / monitoring visits.
Stock management
Ensure that adequate stock levels of all medications (trial and non-trial medications) are maintained at all times and that stock is in date
Ensure that stock management systems are followed at all times.
Maintain adequate stock levels of all starting materials, consumables and packaging components
Perform stock checks at agreed intervals and monitor expiry dates of stock
Other
To participate in weekend and bank holiday working as required
To be current and competent as required by the role, including undertaking training and development consistent with the needs of the department and appropriate to the role.
To work in a helpful, patient-focused and responsive manner to ensure effective communication between the multi-disciplinary team and patients at all times.
Experience
Essential:
Experience working in a Pharmacy team
Previous experience of working in clinical trials
Desirable:
Experience of working in a hospital environment
Experience in an aseptic and/or manufacturing environment
Skills
Essential:
Demonstrates the ability to prioritise workload and carry out tasks independently
Demonstrates the ability to follow all procedures and policies accurately
Able to dispense clinical trial prescription accurately
Able to demonstrate good aseptic technique
Able to perform basic mathematical calculations
Able to meet deadlines
Demonstrates effective customer service skills
Ability to work calmly under pressure, and to a deadline
Able to complete documentation accurately with attention to detail
Desirable:
Demonstrates organisation skills
Intermediate IT skills including email, word processing, spread sheets, accurate data entry, and pharmacy systems
Good verbal and written communication skill; Able to communicate well with all grades of staff in a confident manner
Knowledge
Essential:
Previous knowledge of GCP, GMP, QA and clinical trail legislation
Dispensing and interpreting prescription
Desirable:
Understanding of infection, prevention and control (IPC)
Understand Home Office requirements for Controlled Drugs storage and record keeping
Qualification
GCSE grades A/C or 1-4
English Language
Maths
Double Science
NVQ Level 2 in pharmacy services or equivalent#
Other
Standard DBS check