Clinical Trials Pharmacy Assistant

Oxford University Hospitals NHS Foundation Trust; Oxford; On-site; GBP 26,000 - 34,000; Full time

Job summary

Oxford University Hospitals NHS Foundation Trust is seeking a Senior Clinical Trials Pharmacy Assistant to join the Clinical Trials Pharmacy team in Oxford. You will support Pharmacists, Technicians, Assistants and Practitioners in trial operations and supply chain management.

Responsibilities include drug accountability, sponsor liaison, data collection and preparation for audits while ensuring compliance with GCP and regulatory requirements.

Qualifications

• GCP training is required and maintained.
• Communicate with investigators, research nurses and sponsors.
• Assist with data collection and trial documentation.
• Maintain stock levels, expiry dates and drug accountability.

Responsibilities

• Obtain and maintain GCP training.
• Communicate with trial staff during setup and execution.
• Ensure trial drugs are dispensed per protocol and logged.
• Order, receive, and reconcile clinical trial drugs and paperwork.
• Support preparation for monitoring visits, audits and inspections.

Skills

GCP training

Communication

Data collection

Stock control

Pharmacy knowledge

Education

Pharmacy Skills

Tools

IVRS system

Job description

As a Senior Technician I am privileged to manage and support our fantastic technical team of Pharmacy Technicians, Assistants and Practitioners as we provide support services to clinical trial research teams on all our Trust sites throughout Oxfordshire. The Clinical Trials Pharmacy consists of Pharmacists, Technicians, Assistants and Practitioners . We work closely with research teams across the trust and external representatives.

As a Senior Clinical Trials Pharmacy Assistant in our team, you will have an extremely varied role - you will be involved in maintaining the supply chain of Clinical Trial medications to research nurses who deliver treatment to patients, maintaining financial records, completing drug accountability activities, closing down and archiving of completed studies, as well as facilitating meetings from sponsors.

Responsibilities

• 1. To obtain and maintain Good Clinical Practice (GCP) training.
• 2. To apply principles of GCP in the management of clinical trials and work within the Medicines for Human Use (Clinical Trial) Regulations 2004 and EU directive relating to Clinical Trials.
• 3. To communicate with Investigators, Research Nurses, Trust R&D, Sponsors, Clinical Research Associates and Pharmacy staff during the set-up and running of a clinical trial.
• 4. To ensure clinical trial protocols and SOPs are followed during dispensing of clinical trial investigational medicinal products and other drugs included in the protocol.
• 5. To order and receive in clinical trial drugs, process receipt paperwork and acknowledge receipt on IVRS (Electronic Medication Supply) systems.
• 6. To check stock levels and expiry dates of clinical trial drugs and keep balance logs up to date.
• 7. To assist with the packing down and re-labelling of clinical trial drugs if required.
• 8. To assist with the preparation for monitoring meetings, audits and inspections,
• 9. To maintain Clinical Trial files ensuring items can easily be located and are presentable.
• 10. To process returned clinical trial drugs and ensure the paperwork is kept in order.
• 11. To participate in the statutory temperature monitoring of clinical trial stock.
• 12. To assist with the destruction of clinical trial medication.
• 13. To assist with the closedown and archiving of clinical trial files.
• 14. To represent the Clinical Trials Team to update the dispensary staff at meetings.
• 15. To liaise with Research Nurses to update them on trial progress, stock levels etc.
• 16. To assist in the collection of data as requested by the Senior Clinical Trial Technician or Clinical Trial Pharmacists.
• 17. To assist in maintaining financial records, including the generation of invoices, checking payments etc.
• 18. To assist with general administration such as organising set up meetings etc. and be a point of contact within the Clinical Trials Pharmacy Team.
• 19. To maintain clinical trial filing systems and drug accountability documentation for clinical trials.
• 20. To use the computer system and other information technology in all areas of Pharmacy.

Regulatory

• 1. To assist in non-aseptic preparation and dispensing of clinical trial medication in accordance with the RPSGB code of ethics and current legislation and guidance including Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Health and Safety, Medicines Act, Misuse of Drugs Act, Control of Substances Hazardous to Health (COSHH) and Departmental Procedures.
• 2. To ensure you are familiar with and adhere to Pharmacy, CTASU and Trust standard operating procedures (SOPs).
• 3. To ensure the disposal or recycling of medicinal products is carried out in a safe and efficient manner, in accordance with Health & Safety, COSHH regulations and Departmental Standard Operating Procedure.

Teaching and Training

• 1. To participate in a programme of work based training, development and appraisal.
• 2. To participate in the training and induction of pre-registration students, technicians and assistants (if required).

General responsibilities

• 1. To ensure confidentiality is maintained at all times.
• 2. To be aware of and be involved in good customer service.
• 3. To assist in audit programme.
• 4. To participate in weekend, evening and bank holiday working according to rota.
• 5. Any other reasonable duties as requested.

Risk Management

• 1. The management of risk is the responsibility of everyone and will be achieved within a progressive, honest and open environment.
• 2. Staff will be provided with the necessary education, training and support to enable them to meet this responsibility.
• 3. Staff should be familiar with the + Major incidents Policy + Fire Policy
• 4. The post holder should make themselves familiar with the 'local response' plan and their role within that response.

Responsibilities for Health and Safety

• 1. The post holder is responsible for ensuring that all duties and responsibilities of this post are carried out in compliance with the Health and Safety at Work Act 1974, Statutory Regulations and Trust Policies and Procedures. This will be supported by the provision of training and specialist advice where required.

Infection Control

• 1. Infection Control is everyone's responsibility. All staff, both clinical and non-clinical, are required to adhere to the Trusts' Infection Prevention and Control Policies and make every effort to maintain high standards of infection control at all times thereby reducing the burden of Healthcare Associated Infections including MRSA.
• 2. All staff employed by the ORH Trust has the following key responsibilities: + Staff must wash their hands or use alcohol gel on entry and exit from all clinical areas and/or between each patient contact. + Staff members have a duty to attend mandatory infection control training provided for them by the Trust. + Staff members who develop an infection (other than common colds and illness) that may be transmittable to patients have a duty to contact Occupational Health.

Special Working Conditions

1. The post holder must adhere to associated hygiene and clothing requirements of individual work areas. This may involve: absence of make-up, removal of jewellery, wearing of protective clothing, working in a confined space for up to periods of 3 hours at a time. Please Note: 1. This Post is subject to appraisal, which is a two way process. 2. This job description is not definitive or restrictive in any way and should be regarded only as a guide to the duties required, and also it will be understood that at a time of rapid change within the Health Service other responsibilities may be added, as determined by the Chief Pharmacist. The job description does not form part of the contract of employment. 3. The post-holder will be expected to participate in flexible working if introduced. 4. Out of hours working may be included and participation in such arrangements will be required. 5. Pharmacists will be required to participate in on-call arrangements according to site and experience. 6. Individual's continuous Professional Development needs will be identified and supported.

The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.

A successful candidate should possess BTEC Level 2 in Pharmacy Service Skills, equivalent qualification or related degree (i.e. pharmaceutical or science degree). Applicants without these qualifications will still be considered. However, they will be required to undertake the provided relevant qualification in Pharmacy Service Skills.

Sexual Safety Charter: In 2023 NHS England launched its first sexual safety charter, and our Trust proudly signed it. We pledge zero tolerance for inappropriate sexual behaviour and commit to the ten core principles

Oxford University Hospitals NHS Foundation Trust is one of the largest NHS teaching trusts in the country. It provides a wide range of general and specialist clinical services and is a base for medical education, training and research. The Trust comprises of four hospitals - the John Radcliffe Hospital, Churchill Hospital and Nuffield Orthopaedic Centre in Headington and the Horton General Hospital in Banbury. Our values, standards and behaviours define the quality of clinical care we offer and the professional relationships we make with our patients, colleagues and the wider community. We call this Delivering Compassionate Excellence and its focus is on our values of compassion, respect, learning, delivery, improvement and excellence.

Oxford University Hospitals NHS Foundation Trust is one of the largest NHS teaching trusts in the country. It provides a wide range of general and specialist clinical services and is a base for medical education, training and research. The Trust comprises four hospitals - the John Radcliffe Hospital, Churchill Hospital and Nuffield Orthopaedic Centre in Headington and the Horton General Hospital in Banbury. For more information on OUH please view OUH At a Glance by OUHospitals - Issuu Our values, standards and behaviours define the quality healthcare we would like for ourselves or a member of our family. Watch how we set out to deliver compassionate excellence via the OUH YouTube channel.

Oxford University Hospitals promotes a safe, respectful hiring environment. If you want to make a difference with us, come and join our team. Together, we will uphold the highest standards of care and professionalism.