Job summary
As a member of the Clinical Trials team, you will work closely with other members of the team to ensure that Christie patients have access the latest development of oncology/haematology investigational medicines. The Pharmacy Department are also supporting the large-scale collaborative project alongside several research partners and have strong links with the University of Manchester.
We are wishing to recruit individuals who are enthusiastic, committed, adaptable and flexible to our team. Now is an exciting time to join the Trust as our clinical trial activity continues to grow due to the expansion of phase I experimental cancer medicines and advanced therapies investigational medicinal products (ATIMPs). If you are passionate, keen, and interested in making a positive contribution to the care of cancer patients involved in clinical trials, we want to hear from you.
Main duties of the job
Support all aspects of pharmacy requirements for medicinal products within the context of a clinical trial (handling, dispensing, drug accountability, administration, storage, disposal of medicinal products.
Provide support to ensure activities within the pharmacy department are managed in accordance with the International Conference of Harmonisation Good Clinical Practice Guidelines (ICH-GCP), Good manufacturing Practice (GMP), the Research Governance Framework for Health & Community Care (2001) and the Medicines for Human Use (Clinical Trials) Regulations 2004.
About us
The Christie is one of Europe's leading cancer centres, treating over 60,000 patients a year. We are based in Manchester and serve a population of 3.2 million across Greater Manchester & Cheshire, but as a national specialist around 15% patients are referred to us from other parts of the country. We provide radiotherapy through one of the largest radiotherapy departments in the world; chemotherapy on site and through 14 other hospitals; highly specialist surgery for complex and rare cancer; and a wide range of support and diagnostic services. We are also an international leader in research, with world first breakthroughs for over 100 years. We run one of the largest early clinical trial units in Europe with over 300 trials every year. Cancer research in Manchester, most of which is undertaken on the Christie site, has been officially ranked the best in the UK.
Job description
Job responsibilities
DUTIES AND RESPONSIBILITIES
Clinical trials
- Check pharmacy files for missing data and organise, retrieve, and record data in a timely manner.
- Ensuring clinical trial pre orders and vial allocations are turned around in a timely fashion to prevent any delay in patient treatment
- Work with sponsor IVRS/IWRS for ordering, acknowledging orders.
- Dispensing and preparation of medicines both IV and oral clinical trials in accordance with ICH GCP and study specific sops.
- To provide support to other pharmacy staff in the dispensing of complex clinical trials.
- Use computer-based data storage systems and IVRS/IWRS to record clinical trial activity
- Assist pharmacy team in all areas of R&D administration as required.
- Ensure all drug accountability for all clinical trials are processed accurately and in a timely manner ensuring drug accountability is up to date.
- To participate in the maintenance of pharmacy documentation where required.
- Support regulatory compliance across all clinical research services within pharmacy.
- To perform any other duties as requested by the line manager and/or director of pharmacy.
- To be responsible for own continued personal and professional development through training and review with line manager.
GENERAL
- Undertake daily housekeeping duties
- Be fully aware of COSHH regulations, particularly in relation to health and storage of medicines. Be aware of the Cytotoxic Spill procedure in the event of an accident.
- Report any complaints, incidents, or near misses on the departmental Incident report sheets.
- Be fully aware of all departmental operational policies and carry out procedures in accordance with current legislation.
- Comply with the Health & Safety at work Act.
- Attend regular in house and Trust training sessions to ensure Continued Professional Development. Attend Trust & departmental Mandatory training
- Participate in the extended hours of the department, leading to twelve hour and seven-day week departmental opening. To be able to participate in Saturday working as required by the service. To participate in the required bank holiday working rota
The duties of the post may be varied with the agreement of the employee in accordance with the changing needs and practices of the department and organization. The role should be discussed at least on an annual basis through the preparation of a personal development plan
Job description
Job responsibilities
DUTIES AND RESPONSIBILITIES
Clinical trials
- Check pharmacy files for missing data and organise, retrieve, and record data in a timely manner.
- Ensuring clinical trial pre orders and vial allocations are turned around in a timely fashion to prevent any delay in patient treatment
- Work with sponsor IVRS/IWRS for ordering, acknowledging orders.
- Dispensing and preparation of medicines both IV and oral clinical trials in accordance with ICH GCP and study specific sops.
- To provide support to other pharmacy staff in the dispensing of complex clinical trials.
- Use computer-based data storage systems and IVRS/IWRS to record clinical trial activity
- Assist pharmacy team in all areas of R&D administration as required.
- Ensure all drug accountability for all clinical trials are processed accurately and in a timely manner ensuring drug accountability is up to date.
- To participate in the maintenance of pharmacy documentation where required.
- Support regulatory compliance across all clinical research services within pharmacy.
- To perform any other duties as requested by the line manager and/or director of pharmacy.
- To be responsible for own continued personal and professional development through training and review with line manager.
GENERAL
- Undertake daily housekeeping duties
- Be fully aware of COSHH regulations, particularly in relation to health and storage of medicines. Be aware of the Cytotoxic Spill procedure in the event of an accident.
- Report any complaints, incidents, or near misses on the departmental Incident report sheets.
- Be fully aware of all departmental operational policies and carry out procedures in accordance with current legislation.
- Comply with the Health & Safety at work Act.
- Attend regular in house and Trust training sessions to ensure Continued Professional Development. Attend Trust & departmental Mandatory training
- Participate in the extended hours of the department, leading to twelve hour and seven-day week departmental opening. To be able to participate in Saturday working as required by the service. To participate in the required bank holiday working rota
The duties of the post may be varied with the agreement of the employee in accordance with the changing needs and practices of the department and organization. The role should be discussed at least on an annual basis through the preparation of a personal development plan
Person Specification
Qualifications
Essential
- NVQ 2 or equivalent in Pharmacy Services
Experience
Essential
- Working in a Pharmacy environment
Desirable
- Clinical Trials
- Dispensing experience
- Reconstitution experience
- Previous aseptic environment experience
- Hospital experience
- Good Manufacturing Practice
- Stores handling
- Experience of GMP
- GCP Training
Skills
Essential
- IT skills
- Excellent communication skills
- Able to work alone and as part of a team
- An accurate and logical approach to workloads
- Motivated and flexible
- Ability to undertake physical and manual tasks
- Good time management
- Honest, reliable, and enthusiastic
Desirable
- Stock control and rotation
Knowledge
Desirable
- Knowledge of working with trials.
- Knowledge of aseptic procedures
VALUES
Essential
- Ability to demonstrate the organisational values and behaviours
OTHER
Essential
- Flexibility of working hours
- To be able to participate in weekend or bank holiday working if required by the service.
Person Specification
Qualifications
Essential
- NVQ 2 or equivalent in Pharmacy Services
Experience
Essential
- Working in a Pharmacy environment
Desirable
- Clinical Trials
- Dispensing experience
- Reconstitution experience
- Previous aseptic environment experience
- Hospital experience
- Good Manufacturing Practice
- Stores handling
- Experience of GMP
- GCP Training
Skills
Essential
- IT skills
- Excellent communication skills
- Able to work alone and as part of a team
- An accurate and logical approach to workloads
- Motivated and flexible
- Ability to undertake physical and manual tasks
- Good time management
- Honest, reliable, and enthusiastic
Desirable
- Stock control and rotation
Knowledge
Desirable
- Knowledge of working with trials.
- Knowledge of aseptic procedures
VALUES
Essential
- Ability to demonstrate the organisational values and behaviours
OTHER
Essential
- Flexibility of working hours
- To be able to participate in weekend or bank holiday working if required by the service.
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.
