The post-holder is responsible for planning, delivering and evaluating high standards of the technical pharmacy clinical trials service.
* Is expected to assist the Lead Pharmacist for Clinical Trials in the overall management, development and running of the clinical trials technical service ensuring the provision of a high quality, timely service and to manage and develop the clinical trials/research assistant.
* Is expected to deliver the service without direct supervision. Is accountable for the service and any omissions.
* Is expected to teach and supervise more junior staff, students and rotational staff coming through the department.
* Is accountable for care or any omissions of care that he/she delegates to others.
* Is expected to act as role model, delivering care with empathy and compassion as part of a multidisciplinary team.
Main duties of the job
* To contribute to the provision of a dispensing service for clinical trial patients. To apply and ensure the principles of GCP are adhered to in the management of clinical trials maintain records of dispensing including clinical trial material.
* Under the general direction of the supervising pharmacist and senior pharmacy technician to undertake the day to day management of the pharmacy clinical trials service ensuring an efficient and timely service to all users
* To undertake technical checking of prescriptions as an Accredited Checking Pharmacy Technician and to maintain competences and accreditation in this area.
* To write pharmacy procedures for the management of Investigational Medicinal Products using source documents such as the protocol and pharmacy manual
* To work as part of a team and also work independently and using own initiative to deal with problems, enquiries and urgent requests referring to the senior technician or a pharmacist if necessary.
* To provide administrative cover during periods of staff leave. This includes ordering and receiving of IMPs and administrative duties
* To liaise with CRAs during feasibility visits, Site Initiation visits, monitoring visits
About us
The Royal Berkshire NHS Foundation Trust is the main provider of hospital services for the population of Reading, Newbury, Wokingham and the towns and villages of west Berkshire.At our heart we are a local hospital that works with NHS and social care partners to provide excellent healthcare services for over 500,000 people who currently live in our catchment area. We also provide specialist hospital services beyond the county's borders.
We employ more than 5,500 staff from 39 different nationalities and deliver care from a network of facilities across sites in Bracknell, Henley-on-Thames, Reading, Thatcham and Windsor, offering services such as:
* Acute medical services at RBH in Reading
* Ophthalmology services at Prince Charles Eye Unit, Windsor
* Dialysis services in Windsor
* Day surgery and acute outpatient services at West Berkshire Community Hospital
* Cancer, renal and outpatient services in Bracknell
* Outpatient services at Townlands Hospital, Henley.
As a founder member of the Berkshire West Integrated Care System, we are one of NHS England's demonstrator sites for integration between primary, community, mental health and acute healthcare services.We are actively involved in research and development which supports our high -quality work and benefits both patients and staff. We offer great careers for doctors, nurses, midwives and other professions.
Job description
Job responsibilities
Research
1. Ensure the set-up and supervising the running of the Clinical Trials within the dispensary, monitoring quality and effectiveness.
2. Assist in planning training schedules for staff new to the clinical trials.
3. Assist the Lead Clinical Trials Pharmacist and/or Clinical trials Pharmacist in the setting, reviewing and monitoring of quality standards and organizing audits to improve efficiency for the dispensary.
4. Develop new systems of work as required by service developments.
5. Obtain and keep up to date with Good Clinical Practice (GCP) Training
6. Work within the Medicines for Human Use (Clinical Trial) Regulations 2004 and the EU Directives relating to Clinical Trials and the Research Governance Framework.
7. Review all Clinical Trial protocols which will involve the pharmacy department. This may be prior to Trust Research & Development (R& D) Approval.
8. Participate in confidential communication with the Lead Clinical Trials Pharmacist and/or Clinical trials Pharmacist, Investigators, Research Nurses, Trust R& D, Sponsors, Pharmaceutical Company Clinical Research Associates, Pharmacy Aseptic Services Unit (PASU) staff and dispensary staff during the Pharmacy Approval process, the setting up of new studies and during the running of the study.
9. Develop, implement and maintain clear and accurate written procedures for dispensing for each clinical trial in the dispensaries in accordance with Good Clinical Practice (GCP) and each studys protocol.
10. Ensure Clinical Trial protocols are followed during dispensing of Clinical Trial Investigational Medical Products and other drugs included in the protocol.
11. Maintain and setup systems to reclaim any reimbursement of free or discounted stock of Investigational Medical Product used in Clinical Trials within the dispensaries.
12. Maintain Clinical Trial filing systems.
13. Design drug accountability documentation and prescriptions for Clinical Trials, if required.
14. Conduct auditing and monitoring of Trust research on behalf of the R& D department
Person Specification
Qualifications
Essential
* Achieved grades
Desirable
* years of experience
Appraisal review
Essential
* Achieved grades
Employer details
Employer name
Royal Berkshire NHS Foundation Trust
Address
Royal Berkshire Hospital
1 Craven Road
Reading
RG1 5AN
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