Job summary
- To help manage, develop, organise and maintain the Oncology Pharmacy Clinical Trials Portfolio in conjunction with the Highly Specialist Clinical Trials Pharmacist, ensuring compliance with ICH GCP guidelines, The Research Governance Framework, the E.U Clinical Trials Directive and other relevant guidelines, regulations andpolicies.
- To help manage the training and assessment of pharmacy staff undertaking Clinical trial work within OncologyPharmacy
- Develop, review & revise policies, guidelines and procedures regarding clinical trials services
- To write precise and concise standard operating procedures (SOPs) for each new clinical trial with respect to dispensing, final checking and procurement of Investigational Medicinal Products (IMPs) which are final checked by the Highly Specialist Clinical Trials Pharmacist.
Main duties of the job
To be responsible for the day-to day maintenance of the oncology pharmacy clinical trials portfolio.
Ensuring that all oncology pharmacy clinical trial files contain allnecessary documentation and are kept up todate
Preparing (and update as required) clear and accurate written dispensing procedures for dispensing staff for each clinical trial in accordance with International Conference for Harmonisation for Good Clinical Practice( ICHGCP) and each study's protocol
Preparing (and update as required) clear & accurate final checking procedures for rotational pharmacists in accordance with ICH GCP and each study's protocol
Prepare (and update as required) a clear and accurate written summary of each clinical trials protocol.
Create drug accountability records, patient I.D logs and other documents deemed necessary (where the study sponsor has not alreadyprovided)
Ensure that all files contain copies of all relevant regulatoryapprovals
Review oncology clinical trial documents prior to initiation of a new study, assess the suitability local documents and procedures relating to procurement, storage and dispensing of study medication and make recommendations for changes when appropriate.
Dispensing clinical trials
Manage the security & maintenance of all clinical trial drugs
Responsible for routine monitoring visits and 'close down' procedures for clinical trials
About us
As part of Kings Health Partners, the Oncology and Haematology Clinical Trials (OHCT) team is made up of ninety plus staff members consisting of Research Nurses, Clinical Trial Practitioners, Clinical Trial Coordinators and the Safety & Support Team at Guys' and St Thomas' NHS Foundation Trust. Within the OHCT Pharmacy team there is a mixture of pharmacists technicians and assistant.
We work closely with the oncology and haematology medical teams to recruit patients to our trials and to ensure patients are monitored closely throughout. We have a large portfolio of Phase II and III trials; which are split into teams for specific tumour groups. We also have a team dedicated to early phase trials and run weekly early phase clinics in the Clinical Research Facility. We attract commercial and non-commercial trials, ranging from interventional drug or radiotherapy trials to observational studies.
Our mission statement is 'Improving treatment choice, clinical care and outcomes for cancer patients through innovation, dedication and excellence in clinical trials'.
Job description
Job responsibilities
KeyRelationships
A list of staff the post holder will have regular contact with
Within Pharmacy: Principal Technician Oncology/Aseptic Services, Dispensary managers, Pharmacists and Technical staff.
Others: Research nurses, Investigators (Consultants), Junior Doctors and other research personnel. Representatives from the Pharmaceutical Industry, non-commercials research organisations and regulatory authorities.
Job description
Job responsibilities
KeyRelationships
A list of staff the post holder will have regular contact with
Within Pharmacy: Principal Technician Oncology/Aseptic Services, Dispensary managers, Pharmacists and Technical staff.
Others: Research nurses, Investigators (Consultants), Junior Doctors and other research personnel. Representatives from the Pharmaceutical Industry, non-commercials research organisations and regulatory authorities.
Person Specification
Knowledge/Qualifications
Essential
- Degree in Pharmacology , Pharmaceutical science or equivalent. Or NVQ Level 3 in pharmacy services.
- Dispensing assistant qualification or course will be required to be undertaken as per required timelines
- GCP Training
Desirable
- Registered as a Pharmacy Technician with the General Pharmaceutical Council
- MSC / Diploma
Previous Experience
Essential
- Previous evaluated experience of supervising staff and workload on a day-to-day basis
- Previous evaluated experience of participation in project and audit work
- Professional CPD as defined by General Pharmaceutical Council
Desirable
- Demonstrated experience of ability to appraise staff and set performance objectives
Skills
Essential
- Demonstrated ability to write SOPs
- Demonstrated ability to prioritise and organise routine daily, using own initiative, whilst supervising and leading a team
- Demonstrated ability to work under pressure accurately
- Demonstrated ability to communicate more complex and sensitive information effectively using clear written and spoken English to overcome barriers to understanding
- Demonstrated IT skills including: ? Email ? Word processing ? Spreadsheets Accurate data entry
- Demonstrated ability to clearly and accurately complete complex routine and non-routine documentation.
Desirable
- Demonstrate ability manage performance
- EPIC hyperspace / willow computer systems
Person Specification
Knowledge/Qualifications
Essential
- Degree in Pharmacology , Pharmaceutical science or equivalent. Or NVQ Level 3 in pharmacy services.
- Dispensing assistant qualification or course will be required to be undertaken as per required timelines
- GCP Training
Desirable
- Registered as a Pharmacy Technician with the General Pharmaceutical Council
- MSC / Diploma
Previous Experience
Essential
- Previous evaluated experience of supervising staff and workload on a day-to-day basis
- Previous evaluated experience of participation in project and audit work
- Professional CPD as defined by General Pharmaceutical Council
Desirable
- Demonstrated experience of ability to appraise staff and set performance objectives
Skills
Essential
- Demonstrated ability to write SOPs
- Demonstrated ability to prioritise and organise routine daily, using own initiative, whilst supervising and leading a team
- Demonstrated ability to work under pressure accurately
- Demonstrated ability to communicate more complex and sensitive information effectively using clear written and spoken English to overcome barriers to understanding
- Demonstrated IT skills including: ? Email ? Word processing ? Spreadsheets Accurate data entry
- Demonstrated ability to clearly and accurately complete complex routine and non-routine documentation.
Desirable
- Demonstrate ability manage performance
- EPIC hyperspace / willow computer systems
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.
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 UK Visas and Immigration website (Opens in a new tab).
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. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
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.
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 UK Visas and Immigration website (Opens in a new tab).
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. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
