Job summary
Pharmacy Clinical Trials (Health Science) Associate Practitioner - Band 4 - Permanent
Hello,My name is Lina, I'm a Clinical Trials Pharmacy Team Manager for the Clinical Trials Pharmacy team in Oxford and I'm very excited to share this new and exciting career opportunity with you.
As a team manager I am privileged to manage and support our fantastic technical team of Pharmacy Technicians, Assistants and Associate Practitioners and 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, Practitioners and Associate Practitioners. We work closely with research teams across the trust and external representatives.
If you are interested in an informal discussion about the Pharmacy Clinical Trials (Health Science) Associate Practitioner 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.
Main duties of the job
As a Pharmacy Clinical Trials (Health Science) Associate Practitioner in our team, you will have an extremely varied role.
You will act as the Lead Associate Practitioner for individual clinical trials, being the main point of contact for the clinical trials once open to recruitment. 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 is required to:
* possess NVQ Level 2 in Pharmacy Service Skills OR BTEC Level 2 Certificate in the Principles and Practice for Pharmacy Support
* and have extensive experience of the day-to-day management and handling of IMPs.
Applicants without these essential qualifications will not be considered. Alternative qualifications will not be accepted.
Please make sure that you read the job description and person specification attached, and that your statement in support reflects this as your application will be judged against these criteria.
About us
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 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.
Job description
Job responsibilities
Core Role - Clinical Trials
1. Act as the Lead Practitioner for individual clinical trials being the main point of contact for the clinical trials once open to recruitment.2. Ensure good communication with Investigators, Research Nurses, Trust Research & Development, Sponsors, Clinical Research Associates and Pharmacy staff during the running of a clinical trial. Utilises tact and persuasive skills as needed.3. Ensure good communication with research patients, who may at times be upset, to manage situations and provide an expert service.4. Assists with the preparation for monitoring meetings, audits and inspections, and carry out any necessary work prior to this.5. Maintains Clinical Trial files ensuring items can easily be located and are presentable.6. Liaise with Research Nurses to update them on trial progress, stock levels etc.7. Responsible for the generation of invoices for allocated studies and assist with invoices for other studies as needed.8. Complete GCP checklists for allocated studies on a regular basis as indicated by objectives and procedures and assist in the completion of GCP check lists for other studies
9. Maintain Good Clinical Practice (GCP) training.10. 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.11. To ensure clinical trial protocols and SOPs are followed during dispensing of clinical trial investigational medicinal products and other drugs included in the protocol.12. Close down allocated clinical trials within the timeframes indicated by objectives and procedure and assist in the close down of other studies13. Be competent to: Order, receipt, undertake stock acknowledgement, pack-down, label, undertake returns and destruction of clinical trial IMPs and other medicines. Dispense doses for patients in clinical trials Undertake expiry date and stock level checks are carried out and that stock levels are maintained. Temperature monitor clinical trial stocks and manage an excursion.14. Assist in the collection of data as requested by the Senior Clinical Trial Technician or Clinical Trial Pharmacists.15. Follow SOPs for own area of work. Propose changes or comment on changes to SOPs as required.16. Represent the Clinical Trials Team to update the dispensary staff at meetings.17. Develop knowledge and skills for the safe use of equipment in the department: Waysafe cabinet and take responsibility for its safe use by others.18. Safely handle hazardous materials: chemotherapy, genetically modified investigational medicinal products, other Advanced Therapy
Clinical Trial Aseptic Unit (CTASU)
1. To maintain personal expertise, skills and necessary knowledge of the technical aspects of aseptic and non-aseptic dispensing to undertake the safe and accurate completion of product worksheets and labels, assembly of components for dose preparation, preparation of a wide range of aseptic products.2. Use high levels of precision and accuracy to manipulate components in a gloved isolator to prepare doses accurately and safely for patients.3. To participate in the clean room/isolator cleaning rota.4. To assist in environmental and physical monitoring of the CTASU.5. To be involved in the maintenance and accurate recording of departmental records and results including staff training, environmental monitoring, cleaning, maintenance logs and worksheets.
Job description
Job responsibilities
Core Role - Clinical Trials
1. Act as the Lead Practitioner for individual clinical trials being the main point of contact for the clinical trials once open to recruitment.2. Ensure good communication with Investigators, Research Nurses, Trust Research & Development, Sponsors, Clinical Research Associates and Pharmacy staff during the running of a clinical trial. Utilises tact and persuasive skills as needed.3. Ensure good communication with research patients, who may at times be upset, to manage situations and provide an expert service.4. Assists with the preparation for monitoring meetings, audits and inspections, and carry out any necessary work prior to this.5. Maintains Clinical Trial files ensuring items can easily be located and are presentable.6. Liaise with Research Nurses to update them on trial progress, stock levels etc.7. Responsible for the generation of invoices for allocated studies and assist with invoices for other studies as needed.8. Complete GCP checklists for allocated studies on a regular basis as indicated by objectives and procedures and assist in the completion of GCP check lists for other studies
9. Maintain Good Clinical Practice (GCP) training.10. 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.11. To ensure clinical trial protocols and SOPs are followed during dispensing of clinical trial investigational medicinal products and other drugs included in the protocol.12. Close down allocated clinical trials within the timeframes indicated by objectives and procedure and assist in the close down of other studies13. Be competent to: Order, receipt, undertake stock acknowledgement, pack-down, label, undertake returns and destruction of clinical trial IMPs and other medicines. Dispense doses for patients in clinical trials Undertake expiry date and stock level checks are carried out and that stock levels are maintained. Temperature monitor clinical trial stocks and manage an excursion.14. Assist in the collection of data as requested by the Senior Clinical Trial Technician or Clinical Trial Pharmacists.15. Follow SOPs for own area of work. Propose changes or comment on changes to SOPs as required.16. Represent the Clinical Trials Team to update the dispensary staff at meetings.17. Develop knowledge and skills for the safe use of equipment in the department: Waysafe cabinet and take responsibility for its safe use by others.18. Safely handle hazardous materials: chemotherapy, genetically modified investigational medicinal products, other Advanced Therapy
Clinical Trial Aseptic Unit (CTASU)
1. To maintain personal expertise, skills and necessary knowledge of the technical aspects of aseptic and non-aseptic dispensing to undertake the safe and accurate completion of product worksheets and labels, assembly of components for dose preparation, preparation of a wide range of aseptic products.2. Use high levels of precision and accuracy to manipulate components in a gloved isolator to prepare doses accurately and safely for patients.3. To participate in the clean room/isolator cleaning rota.4. To assist in environmental and physical monitoring of the CTASU.5. To be involved in the maintenance and accurate recording of departmental records and results including staff training, environmental monitoring, cleaning, maintenance logs and worksheets.
Person Specification
Essential Qualities
Essential
* BTEC / NVQ Level 2 Pharmacy Services
* GCSE or equivalent Level 4 or above in Maths, English and Science
* Extensive experience of the day-to-day management and handling of IMPs
* Completed GCP training and has a good knowledge and understanding of how it affects pharmacy responsibilities and IMP management
* Ability to work fully gloved and gowned in an isolator
* Ability to show attention to detail in work
* Good interpersonal skills with all levels of staff
* Ability to work within SOPs
* Understand when to escalate issues found and can resolve simple issues
* Ability to convey information accurately - verbally and written reports or email
* Professional approach and experience of team working
* Enthusiastic and responsible attitude towards work
* Good organisational skills and prioritisation of work
* Able to work alone and able to use own initiative
* To work with hazardous medicines including ATMPs/GMOs, handle dry ice safely
* Computer literate with experience of working with the Microsoft Office package
Desirable
* Science degree BSc
* NHS experience
* Aseptic experience
* Awareness of legislation and standards relating to Good Clinical Practice
* Able to acknowledge, appreciate and conform to change that occurs
* Experience of working on own initiative
Person Specification
Essential Qualities
Essential
* BTEC / NVQ Level 2 Pharmacy Services
* GCSE or equivalent Level 4 or above in Maths, English and Science
* Extensive experience of the day-to-day management and handling of IMPs
* Completed GCP training and has a good knowledge and understanding of how it affects pharmacy responsibilities and IMP management
* Ability to work fully gloved and gowned in an isolator
* Ability to show attention to detail in work
* Good interpersonal skills with all levels of staff
* Ability to work within SOPs
* Understand when to escalate issues found and can resolve simple issues
* Ability to convey information accurately - verbally and written reports or email
* Professional approach and experience of team working
* Enthusiastic and responsible attitude towards work
* Good organisational skills and prioritisation of work
* Able to work alone and able to use own initiative
* To work with hazardous medicines including ATMPs/GMOs, handle dry ice safely
* Computer literate with experience of working with the Microsoft Office package
Desirable
* Science degree BSc
* NHS experience
* Aseptic experience
* Awareness of legislation and standards relating to Good Clinical Practice
* Able to acknowledge, appreciate and conform to change that occurs
* Experience of working on own initiative
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 .
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. .
Additional information
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 .
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. .
Employer details
Employer name
Oxford University Hospitals NHS Foundation Trust
Address
Cross site: Churchill Hospital / John Radcliffe Hospital
Oxford
OX3 7LE
Employer's website #J-18808-Ljbffr