Job summary
Working within procedures and meeting required deadlines under the supervision of the Technical staff. Duties will be split 50/50 between the QMC sterile production unit and the QMC clinical trials dispensary.
Within the clinical trials dispensary, to assist the pharmacy team in providing a high quality service to patients, clinical staff and sponsors in the provision of pharmacy services in trials of Investigational Medicinal Products, ensuring compliance with standards of clinical trial management as outlined in NUH Trust Clinical Trials Policy, Guidelines for the Safe and Secure Handling of Medicines, relevant and applicable EU and UK legislation and the UK policy framework for health and social care research 2017
Within pharmacy production, to contribute and assist in the overall aspects of sterile and non-sterile production including organisation, supervision, production and transportation to ensure a high-quality, safe, timely and consistent service.
The post holder will be based at Queens Medical Centre (QMC campus) but may on occasion be expected to work across both QMC and City campuses as required by the needs of the service.
Main duties of the job
To assist in the provision of pharmacy services in trials of Investigational Medicinal Products, ensuring compliance with standards of clinical trial management as outlined in NUH Trust Clinical Trials Policy, Guidelines for the Safe and Secure Handling of Medicines, relevant and applicable EU and UK legislation and the Research Governance Framework for Health and Social Care 2005.
The post holder will be based at QMC Campus and may occasionally be expected to rotate between campuses, as required by the needs of the service.
About us
NUH is an acute care, research active teaching hospital who in partnership with Nottingham University hosts a Clinical Research Facility conducting research into hearing, digestive, respiratory and musculoskeletal disease, mental health and imaging.
NUH recognises the vital role pharmacy has in the management of robust clinical research and NUH Research and Innovation department supports some of our posts to ensure we can deliver a safe, efficient and responsive clinical trials service.
You will have a close working relationship with all members of the pharmacy trials and pharmacy sterile production team of pharmacists, technicians and assistants and have regular contact with clinical research staff and Pharmaceutical companies.
Job description
Job responsibilities
To participate in the receipt and appropriate storage of clinical trial materials from external suppliers, according to procedures, under supervision of the technical staff
To participate in the dispatch of clinical trial materials to external suppliers and other clinical trials pharmacies, according to procedures, meeting required delivery times, under supervision of the technical staff
To be responsible for the required environmental monitoring of clinical trials storage areas according to procedures, under supervision of the technical staff
To participate in the accountability of clinical trials medicines returned by trial subjects, according to procedures, under supervision of the technical staff
Following appropriate training and validation, the post holder will undertake dispensing duties for a range of clinical trials protocols.
On completion of the in house training check list, validations and manufacturing competence assessment, following standard operating procedures:
- Manufacture complex aseptic products including biological and clinical trial preparations in
- Non-sterile manufacture and batch production of IMPs, according to procedures, under supervision of the technical staff.
- Complete worksheets and assemble products, in order to prepare for manufacture of biological and clinical trial preparations.
Assist in the stock control and the stock maintenance of medicinal and non-medicinal products.
See the attached job description for a full list of responsibilities for this role.
Job description
Job responsibilities
To participate in the receipt and appropriate storage of clinical trial materials from external suppliers, according to procedures, under supervision of the technical staff
To participate in the dispatch of clinical trial materials to external suppliers and other clinical trials pharmacies, according to procedures, meeting required delivery times, under supervision of the technical staff
To be responsible for the required environmental monitoring of clinical trials storage areas according to procedures, under supervision of the technical staff
To participate in the accountability of clinical trials medicines returned by trial subjects, according to procedures, under supervision of the technical staff
Following appropriate training and validation, the post holder will undertake dispensing duties for a range of clinical trials protocols.
On completion of the in house training check list, validations and manufacturing competence assessment, following standard operating procedures:
- Manufacture complex aseptic products including biological and clinical trial preparations in
- Non-sterile manufacture and batch production of IMPs, according to procedures, under supervision of the technical staff.
- Complete worksheets and assemble products, in order to prepare for manufacture of biological and clinical trial preparations.
Assist in the stock control and the stock maintenance of medicinal and non-medicinal products.
See the attached job description for a full list of responsibilities for this role.
Person Specification
GCSEs/equivalent in maths and english
Essential
- GCSE (or equivalent) grade 4 (grade C) or above in Maths and English Language
Qualifications
Essential
- Must be in possession of NVQ level 2 (or equivalent) to work as a Band 3. If undertaking or completing this qualification, the successful applicant will be a Band 2 until qualification is gained.
- Possession of, or willing to undertake, or complete NVQ level 2 Pharmacy Services (or equivalent) including relevant modules for this post
- To be able to learn new skills and knowledge and to implement these into standard practice to maintain competencies through validation
Desirable
- Level 2 dispensing or production NVQ/equivalent
Previous pharmacy experience
Desirable
- Prior experience working in a relevant pharmacy role
IT knowledge
Desirable
- Evidence of relevant IT experience, including Office and/or pharmacy specific systems
Accuracy
Desirable
- Evidence of being able to give attention to detail and to keep accurate records
Communication skills and teamwork
Desirable
- Evidence of good communication skills and ability to work flexibly with a team
Person Specification
GCSEs/equivalent in maths and english
Essential
- GCSE (or equivalent) grade 4 (grade C) or above in Maths and English Language
Qualifications
Essential
- Must be in possession of NVQ level 2 (or equivalent) to work as a Band 3. If undertaking or completing this qualification, the successful applicant will be a Band 2 until qualification is gained.
- Possession of, or willing to undertake, or complete NVQ level 2 Pharmacy Services (or equivalent) including relevant modules for this post
- To be able to learn new skills and knowledge and to implement these into standard practice to maintain competencies through validation
Desirable
- Level 2 dispensing or production NVQ/equivalent
Previous pharmacy experience
Desirable
- Prior experience working in a relevant pharmacy role
IT knowledge
Desirable
- Evidence of relevant IT experience, including Office and/or pharmacy specific systems
Accuracy
Desirable
- Evidence of being able to give attention to detail and to keep accurate records
Communication skills and teamwork
Desirable
- Evidence of good communication skills and ability to work flexibly with a team
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.