An exciting opportunity has arisen for an experienced, enthusiastic, self-motivated pharmacy technician to join the pharmacy Clinical Trials Management Team at Leeds Teaching Hospitals NHS Trust.
Applicants should have experience of working with clinical trials and an understanding of Clinical Trial Regulations and Good Clinical Practice.
You will need to have excellent communication skills, be flexible, reliable and able to work using your own initiative. You should have accredited accuracy checking experience.
This post is based at St James University Hospital, but you may be required to work occasionally at other sites to support the service.
Main duties of the job
In this role you will lead, develop and support technical systems and processes to facilitate and streamline the assessment, pharmacy set-up and ongoing management of all types of clinical trials conducted within LTHT.
You will play a key role in the sign off of SOPs covering pharmacy aspects of all new studies and provide input on behalf of pharmacy during the NCVR process, ensuring the appropriate costings for new studies are agreed.
As a senior member of the clinical trials management team you will act as a key point of contact with a number of internal and external teams including clinical pharmacists, aseptics services, the Clinical Research Facility team, investigators and research nurses, the Trust Research & Innovation team and pharmaceutical companies.
You will raise the profile of clinical trials within the Trust, assisting in the provision of training to pharmacy staff on GCP, guidelines, and policies and procedures relating to clinical trials.
As lead technician you will facilitate clinical trial audits and inspections by trial sponsors, pharmaceutical companies and regulatory agencies.
You will lead and manage the implementation of databases and IT systems to provide information on clinical trial activity and monitor Key Performance Indicators, and assist the Clinical Trial Services Manager and Clinical Trials and R& I Lead Pharmacist to set the strategic direction for the technical element of the service.
About us
Leeds Teaching Hospitals NHS Trust is one of the largest teaching hospitals in the UK with a large number of specialised and highly specialised services. It has an established reputation as a Centre of Excellence for delivering high quality research and innovation on a large scale with pharmacy currently supporting over 350 clinical trials across all hospital sites.
Leeds is a wonderful city to work in and LTHT is an organisation that puts its patients first and highly values and supports its staff. Pharmacy is a forward-thinking department that values the contribution of all our staff and is recognised in the organisation for our collaborative working as we continuously support our workforce to develop to their potential in delivering the best patient care.
As a large teaching hospital we operate a weekend, evening and Bank Holiday service in our inpatient dispensaries. You will be required to work these on a rotational basis.
Job description
Job responsibilities
1. Be responsible on a day-to-day basis for efficient and effective management of the technical elements of the pharmacy clinical trial service.
2. Provide specialist technical leadership for the pharmacy clinical trial service.
3. Ensure all technical and support staff are appropriately trained to perform the range of duties required for service delivery.
4. Review and maintain a competency framework for staff working within the pharmacy clinical trial service.
5. Drive, plan and implement developments in the clinical trials service in order to meet the needs of service users.
6. Support and maintain a high quality service, conducted according to international regulations (ICH/GCP) to users within the Pharmacy department, throughout the Trust and external customers.
7. Ensure that activities involved in the provision of clinical trial services receive appropriate remuneration so as not to incur costs to the Trust.
8. Ensure departmental work is completed within agreed deadlines.
9. Line management and supervision of technical staff within the specialist area.
10. Direct and support staff assigned to the specific area on rotation.
11. Be responsible for training and development, attendance management including co-ordination of annual leave and lieu time for technical and support staff.
12. Be responsible for providing suitable training and induction procedures on clinical trial procedures.
13. Maintain links with other senior technicians, managers and other pharmacy staff to ensure a safe and efficient service.
14. Ensure equipment and materials are used responsibly relating to Trust risk assessments.
15. Ensure all staff comply with Trust and Pharmacy Policies and Procedure.
16. Report departmental statistics, including dispensing errors and incidents, to the Clinical Trial Management Team on a monthly basis.
Person Specification
Experience
Essential
* Procedure writing
* Knowledge of current UK medicines legislation in relation to clinical trials
* Comprehensive experience of clinical trials, dispensing and management of change processes.
* Substantial post qualification experience of hospital pharmacy, including at specialist pharmacy technician team leader level.
Desirable
* Developing and implementation of procedures
* Managing budgets
Qualifications
Essential
* NVQ Level 3 in Pharmacy Services or equivalent
* Registrant of General Pharmaceutical Council
Desirable
* Good Clinical Practice Certification
Skills and Behaviours
Essential
* Good time management and problem solving skills
* Able to influence and persuade others
* Able to cope with conflict and handle difficult situations
* Can adapt to a flexible way of working
Employer details
Employer name
Leeds Teaching Hospitals
Address
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
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