Job summary
Manage the pharmacy clinical trials service to Princess Alexandra Hospital Trust .
Responsible for ensuring the efficient set-up and close-down of all clinical trials involving Pharmacy.
Responsible for overseeing and coordinating the Investigational Medicinal Product (IMP) management of all clinical trials.
All work must be carried out in accordance with the International Conference on Harmonisation Good Clinical Practice (ICH-GCP), the European Clinical Trials Directive, Research Governance and local standard operating procedures (SOPs) and policies.
Liaise with a broad professional group within and outside the Trust and research Sponsors.
To assist with the planning and implementation of service development.
To complete the Regional Accredited Technician Checking Scheme (ACPT)
To assist with the stock management of Named Patient medication.
Participate in the provision of Pharmacy Services; to the Trusts hospitals, community clinics and external providers.
Main duties of the job
Scope and range
This role supports and is part of the Research and Development (R&D) Team serving The Princess Alexandra Hospital NHS Trust.
To have a good working knowledge of ICH-GCP, acquired through national training courses and CPD, and keep up to date in accordance with trust and national requirements.
To ensure the smooth day to day running of all aseptic and non-aseptic pharmaceutical clinical trials within Pharmacy.
To ensure clinical trial medicines are dispensed and checked in a timely manner.
To work closely with the Research Nurses and other members of the R&D team.
To actively promote research and raise the profile of research within Pharmacy and the Trust.
Ensure that all professional and legal standards are adhered to.
Ensure all Health & Safety standards in compliance with Trust policies and procedures are followed.
About us
The Princess Alexandra Hospital NHS Trust (PAHT) is proud to care for the communities of West Essex, delivering safe, compassionate, and high-quality services. We are part of the Neighbourhood Wave; a national programme thats changing how care is delivered by focusing on prevention, early support, and more joined-up services across health, social care, and the voluntary sector.
This means were working more closely with local partners to bring care closer to home and support people to live healthier, more independent lives.
Were a supportive and inclusive organisation that values its people. We offer development opportunities, flexible working, and a strong focus on wellbeing. As a Disability Confident and equal opportunities employer, we welcome applicants from all backgrounds and experiences.
Join us and help shape the future of care in West Essex.
Job description
Job responsibilities
Duties and responsibilities
Clinical Trials
- To provide and co-ordinate the pharmaceutical aspects of clinical trials for the Trust.
- To have a good working knowledge of ICH-GCP, acquired through national training courses and continual professional development, and keep up-to-date in accordance with Trust and national requirements.
- To write and update the department clinical trial SOPs in accordance with good clinical practice, European Clinical Trials Directive and any other relevant legislation and guidance.
- To ensure the department clinical trial SOPS are adhered to by all pharmacy staff involved in dispensing clinical trials.
- To coordinate a portfolio of clinical trials across various Trust locations and clinical specialities.
- To liaise with clinical trial representatives of the pharmaceutical industry, clinicians, trial coordinators, nursing and pharmacy staff to ensure that all clinical trials involving pharmacy are conducted appropriately and comply with all relevant legislation and guidance.
- To review clinical trial protocols, provide pharmaceutical input to research staff, advise on the potential impact on pharmacy workload and provide appropriate timescales for trial set-up and initiation.
- To coordinate the pharmaceutical aspects of clinical trials: organisation of supply, storage and quality control of Investigational Medicinal Products (IMPs).
- To produce and implement IMP management procedures and documents for individual clinical trials, to enable accurate record keeping of the receipt, storage, stock control, temperature monitoring, dispensing, return and destruction of IMPs.
- To calculate, negotiate and agree pharmacy trial fees in accordance with national costing templates, monitor ongoing costs and liaise with Trust finance department and/or head of R&D.
- To oversee the accurate and smooth running of clinical trials including IMP management, dispensing, record keeping and stock control within pharmacy on a day to day basis.
- To supervise, or undertake if required, the dispensing of clinical trial prescriptions.
- To undertake final accuracy checks for clinical trial prescriptions within agreed SOPs.
- To assist in the implementation and operation of future plans and developments within the pharmacy clinical trials service.
- To supervise, or undertake if required, the raising of invoices for payment of commercial clinical trials.
- To attend Trust, Health Care Group (HCG) and external meetings and study days concerned with clinical trials.
- To provide information and advice to senior pharmacy managers on the potential clinical and cost implications of clinical trials to enable appropriate information to be given to the Pharmacy Senior Leadership Team, Health Care Groups and the R&D Committee as necessary.
- To provide clinical trials related education, training, supervision and assessment to pharmacy staff in order to facilitate learning and professional development.
- To attend site initiation visits.
- To be actively involved in feasibility.
To act as an Accredited Checking Technician in Clinical Trials
- To complete the Regional Checking Accreditation qualification.
- To act as an accredited checking technician (ACPT) for final accuracy checks of dispensed medication to ensure safe and accurate dispensing of clinical trial prescriptions.
- To maintain the Regional Checking Accreditation qualification by being an ACPT for final accuracy checks of dispensed medication in the Pharmacy Dispensary for two hours each week.
To assist in the service development of Clinical Trials
- Act as a pharmacy representative for meetings and project groups across the organisation.
- Assist the pharmacy department achieve short, medium- and long-term objectives, through effective leadership and performance targets.
To manage, supervise and undertake the training in Clinical Trials of:
- Rotational Pharmacists, Pre-Registration Pharmacists, Pharmacy Assistant Technical Officers, Pharmacy Pre-Registration Technical Officers, Pharmacy Medical Technical Officers (MTO), and Vocational/Work Experience students.
- Ensure training records are maintained.
- Carry out yearly Appraisal and Development Plan process with core and rotational.
To carry out the following in Clinical Trials and all other areas of Pharmacy
- Maintain stock control and stock rotation.
- Follow all standard operating procedures (SOP’s) accurately.
- Maintain a clean and tidy working environment.
- Maintain accurate manual and computer records.
- ‘house-keeping’ duties.
- Ensure disposal of pharmaceutical waste is carried out according to SOP’s.
- Identify pharmaceutical items which are unavailable and follow appropriate SOP.
- Ensure any problems are referred on to the most appropriate member of staff, where necessary.
- Ensure professional and legal standards are adhered to.
- All work will be checked by a pharmacist and or the designated staff in accordance with SOP’s, except for areas covered by a competency framework agreed by the Chief Pharmacist.
- Promote effective communication between the service customers in order to maximise efficiency.
- Ensure action for drug/drug related recalls is carried out in accordance with SOP’s.
- To act as a role model for colleagues.
This job description may be subject to change according to the varying needs of the service. Such changes will be made after discussion between the post holder and the manager. All duties must be carried out under supervision or within Trust policy and procedure.
Job description
Job responsibilities
Duties and responsibilities
Clinical Trials
- To provide and co-ordinate the pharmaceutical aspects of clinical trials for the Trust.
- To have a good working knowledge of ICH-GCP, acquired through national training courses and continual professional development, and keep up-to-date in accordance with Trust and national requirements.
- To write and update the department clinical trial SOPs in accordance with good clinical practice, European Clinical Trials Directive and any other relevant legislation and guidance.
- To ensure the department clinical trial SOPS are adhered to by all pharmacy staff involved in dispensing clinical trials.
- To coordinate a portfolio of clinical trials across various Trust locations and clinical specialities.
- To liaise with clinical trial representatives of the pharmaceutical industry, clinicians, trial coordinators, nursing and pharmacy staff to ensure that all clinical trials involving pharmacy are conducted appropriately and comply with all relevant legislation and guidance.
- To review clinical trial protocols, provide pharmaceutical input to research staff, advise on the potential impact on pharmacy workload and provide appropriate timescales for trial set-up and initiation.
- To coordinate the pharmaceutical aspects of clinical trials: organisation of supply, storage and quality control of Investigational Medicinal Products (IMPs).
- To produce and implement IMP management procedures and documents for individual clinical trials, to enable accurate record keeping of the receipt, storage, stock control, temperature monitoring, dispensing, return and destruction of IMPs.
- To calculate, negotiate and agree pharmacy trial fees in accordance with national costing templates, monitor ongoing costs and liaise with Trust finance department and/or head of R&D.
- To oversee the accurate and smooth running of clinical trials including IMP management, dispensing, record keeping and stock control within pharmacy on a day to day basis.
- To supervise, or undertake if required, the dispensing of clinical trial prescriptions.
- To undertake final accuracy checks for clinical trial prescriptions within agreed SOPs.
- To assist in the implementation and operation of future plans and developments within the pharmacy clinical trials service.
- To supervise, or undertake if required, the raising of invoices for payment of commercial clinical trials.
- To attend Trust, Health Care Group (HCG) and external meetings and study days concerned with clinical trials.
- To provide information and advice to senior pharmacy managers on the potential clinical and cost implications of clinical trials to enable appropriate information to be given to the Pharmacy Senior Leadership Team, Health Care Groups and the R&D Committee as necessary.
- To provide clinical trials related education, training, supervision and assessment to pharmacy staff in order to facilitate learning and professional development.
- To attend site initiation visits.
- To be actively involved in feasibility.
To act as an Accredited Checking Technician in Clinical Trials
- To complete the Regional Checking Accreditation qualification.
- To act as an accredited checking technician (ACPT) for final accuracy checks of dispensed medication to ensure safe and accurate dispensing of clinical trial prescriptions.
- To maintain the Regional Checking Accreditation qualification by being an ACPT for final accuracy checks of dispensed medication in the Pharmacy Dispensary for two hours each week.
To assist in the service development of Clinical Trials
- Act as a pharmacy representative for meetings and project groups across the organisation.
- Assist the pharmacy department achieve short, medium- and long-term objectives, through effective leadership and performance targets.
To manage, supervise and undertake the training in Clinical Trials of:
- Rotational Pharmacists, Pre-Registration Pharmacists, Pharmacy Assistant Technical Officers, Pharmacy Pre-Registration Technical Officers, Pharmacy Medical Technical Officers (MTO), and Vocational/Work Experience students.
- Ensure training records are maintained.
- Carry out yearly Appraisal and Development Plan process with core and rotational.
To carry out the following in Clinical Trials and all other areas of Pharmacy
- Maintain stock control and stock rotation.
- Follow all standard operating procedures (SOP’s) accurately.
- Maintain a clean and tidy working environment.
- Maintain accurate manual and computer records.
- ‘house-keeping’ duties.
- Ensure disposal of pharmaceutical waste is carried out according to SOP’s.
- Identify pharmaceutical items which are unavailable and follow appropriate SOP.
- Ensure any problems are referred on to the most appropriate member of staff, where necessary.
- Ensure professional and legal standards are adhered to.
- All work will be checked by a pharmacist and or the designated staff in accordance with SOP’s, except for areas covered by a competency framework agreed by the Chief Pharmacist.
- Promote effective communication between the service customers in order to maximise efficiency.
- Ensure action for drug/drug related recalls is carried out in accordance with SOP’s.
- To act as a role model for colleagues.
This job description may be subject to change according to the varying needs of the service. Such changes will be made after discussion between the post holder and the manager. All duties must be carried out under supervision or within Trust policy and procedure.
Person Specification
Qualifications
Essential
- Completion of GCP.
- Pharmacy qualification knowledge of pharmaceutical technical
- procedures for specialist area to degree or equivalent level gained
- through training, NVQ3, BTEC in pharmaceutical science or equivalent
- and experience.
- Registered with the General Pharmaceutical Council.
Desirable
- Leadership Qualification.
- Regional Checking Accreditation (ACPT).
Experience
Essential
- Pharmaceutical experience and proven leadership experience.
- Hospital experience, Aseptic, Stores, Dispensary and Ward based
- services.
- Experience of training Pharmacy staff.
- Proven leadership experience.
Desirable
- Experience of automated pharmacy dispensing systems.
Person Specification
Qualifications
Essential
- Completion of GCP.
- Pharmacy qualification knowledge of pharmaceutical technical
- procedures for specialist area to degree or equivalent level gained
- through training, NVQ3, BTEC in pharmaceutical science or equivalent
- and experience.
- Registered with the General Pharmaceutical Council.
Desirable
- Leadership Qualification.
- Regional Checking Accreditation (ACPT).
Experience
Essential
- Pharmaceutical experience and proven leadership experience.
- Hospital experience, Aseptic, Stores, Dispensary and Ward based
- services.
- Experience of training Pharmacy staff.
- Proven leadership experience.
Desirable
- Experience of automated pharmacy dispensing 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.
