Job Description
Senior Clinical Trials Assistant – Band 3 - Permanent
Hello! My name is Helen Elmore and I am one of the Specialist Senior Clinical Trial Technicians for the Clinical Trials Pharmacy team in Oxford.
As a Senior Technician I am privileged to manage and support our fantastic technical team of Pharmacy Technicians, Assistants and Apprentices 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 and Assistants. We work closely with research teams across the trust and external representatives.
If you are interested in an informal discussion about the Pharmacy Assistant role offered within our team then I would be very pleased to chat with you. You are more than welcome to call on the numbers below or even better, we can make an appointment for me to show you around and answer your questions. I look forward to hearing from you.
The majority of correspondence will be via the e-recruitment system; therefore you should check your emails regularly including junk mail folders in web-based email products.
As a Senior Clinical Trials 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. A successful candidate should possess NVQ 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 level 2 qualification in Pharmacy Services and offered a lower band until this qualification is achieved.
Please make sure that you read the job description and person specification attached below, and that your statement in support reflects this as your application will be judged against these criteria.
Oxford University Hospitals NHS Foundation Trustis 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. Find out more here www.ouh.nhs.uk
The Trust comprises of four hospitals - theJohn Radcliffe Hospital,Churchill HospitalandNuffield Orthopaedic Centrein Headington and theHorton General Hospitalin Banbury.
Core Role - Clinical Trials
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. To assist in maintaining financial records, including the generation of invoices, checking payments etc.
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
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.
I am very keen to hear from you if you have previously worked in a pharmacy environment and/or have some exposure to clinical trials as we have some great opportunities for you to progress your career.
If you have any questions, please do not hesitate to reach out.
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