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To support the Pharmacy Clinical Trials Manager in the delivery of all clinical trials within Chelsea and Westminster Hospital NHS Trust (C&W) that have an Investigational Medicinal Product (IMP) involved in the research.
To deputise for the Pharmacy Clinical Trials Manager in their absence with relevant support from appropriate Lead Directorate Pharmacists.
To ensure that all clinical trials are carried out within the ethical and legal frameworks and meet the requirements of Good Clinical Practice (GCP), with optimal regard for documentation and patient safety.
To support the Pharmacy Clinical Trials Manager in the co-ordination and operational management of training of pharmacy staff and the research team in study specific policies and procedures.
To support delivery of the Clinical Governance Agenda in relation to medicines drug use with the Trust
To support the Pharmacy Clinical Trials Manager in the delivery of all clinical trials within Chelsea and Westminster Hospital NHS Trust (C&W) that have an Investigational Medicinal Product (IMP) involved in the research.
To deputise for the Pharmacy Clinical Trials Manager in their absence with relevant support from appropriate Lead Directorate Pharmacists.
To ensure that all clinical trials are carried out within the ethical and legal frameworks and meet the requirements of Good Clinical Practice (GCP), with optimal regard for documentation and patient safety.
To support the Pharmacy Clinical Trials Manager in the co-ordination and operational management of training of pharmacy staff and the research team in study specific policies and procedures.
To support delivery of the Clinical Governance Agenda in relation to medicines drug use with the Trust
About us
1.
Clinical Trials
To support the Pharmacy Clinical Trials Manager to lead and manage the development and delivery of specialist pharmacy services within clinical trials to ensure that;
All clinical trials that include an IMP comply with the Trust guidelines, protocols and policies and that they are set up following the Pharmacy Clinical Trials Policy (PTCP). (This includes making sure that no clinical trial can start without the appropriate approvals and are compliant with current law, regulations and policies).
Professional input is provided to the Sponsor regarding the legal procurement of IMP in line with clinical trial legislation.
The review of any contracts that exist for clinical trials where pharmacy are involved is performed when necessary. (To include Technical Agreements with any third party providers and sponsors).
An in-depth review of all Clinical Trial proposals that include IMPs is carried out as needed.
Trust policies that protect trial participants involved in clinical trials containing IMPs are continually reviewed and developed.
A specialist link between Pharmacy and the Trust R&D department exists.
Any variances in practice of clinical trials are referred to the Deputy Chief Pharmacist Clinical Support for resolution.
Liaison with the relevant Lead Directorate Pharmacists (LDPs) exits to assure:
o Sufficient resources are available to participate in any clinical trial, including technical services and dispensary leads if appropriate.
o Protocols are clinically reviewed and deemed appropriate for use within the directorate to enable sign off of the R&D form by the relevant LDP
A complete clinical trial file is maintained for each clinical trial that clearly documents all activity and processes. Key activities outlined in the PCTP include (not an exhaustive list):
v Ensuring that procurement of IMPs is legal
v Ensuring accurate documentation (receipt, issue and destruction)
v Ensuring appropriate storage of IMPs
v Ensuring that all clinical trials are archived appropriately following the PCTP.
v Ensure that the communication and service to all trial sponsors and investigators is of the highest quality
v Undertake pharmacy audits of all clinical trials involving IMPs working closely with the relevant LDPs and provide written reports of the audits to the Pharmacy Clinical Trials Manager.
v Provide appropriate assistance in emergency situations that require a code break.
Where any responsibility is delegated to an investigator (e.g. storage of an IMP in a clinical area) that the investigators are clear regarding the responsibilities they have for documentation and monitoring. Undertake spot checks on this monitoring and escalate any problems to the relevant LDP.
All relevant staff receive appropriate training and receive relevant information updates regarding the set up and procedures for all clinical trials that may impact upon them, including dispensary, buying office and stores staff.
Evidence of all systems and processes is available to the MHRA on request, including licences, ethics, R&D and Trust approvals.
Assistance is provided for any relevant inspections or audits of clinical trials e.g. MHRA, CRO or Pharmaceutical Industry and respond to the findings of any IMP recommendations, develop and implement an action plan as appropriate.
Departmental policies and SOPs relating to clinical trials are maintained and updated appropriately, in line with new guidance or legislation.
2.
Leadership
Act as a role model for all Pharmacy Technicians, junior pharmacists and pre-registration pharmacists.
Promote best practice e.g. evidence-based practice through prescription monitoring.
Deliver the clinical governance agenda in relation to medicines used within clinical trials
Follow agreed clinical governance initiatives such as incident/error reporting.
3.
Management of service
Ensure national and local agendas are delivered.
Follow and conform to relevant standards of care.
Identify and manage risks in relation to medicines use according to policy/protocol.
Delegate duties/responsibilities appropriately to other trained clinical trial staff.
Evaluate the performance of junior staff against identified criteria using departmental/Trust performance review tools and General Level Competence Framework.
4.
Clinical Practice
Participate in the checking of inpatient, outpatient, clinical trial and ward or clinic based prescriptions by undertaking the HEE LaSE Region Accredited Checking Technicians (ACPT) scheme in line with departmental policy or has previously been accredited and is now recorded on the HEE LaSE ACPT database. All ACPT technicians must demonstrate competence of practice through the GPhC Continuing Fitness to Practice and Organisational Professional Development Reviews.
Counsel patients in order to provide effective and appropriate advice to patients on medication use in order to ensure their understanding of their clinical trial medication in line with specific study protocols and pharmacy procedures, referring to appropriate members of the pharmacy and/or research team when appropriate.
Demonstrate professional accountability to patients.
Deal with queries and issues from patients and other clinical trial staff.
Effectively contend with informal / verbal complaints from research staff or patients in the first instance before appropriate referral to line manager if necessary.
Make appropriate referrals where necessary.
5. Clinical Governance
Demonstrate awareness and commitment to the Trusts Clinical Governance Agenda.
6. Evaluation of Service
Document the workload and quality of clinical trials in line with departmental and corporate objectives.
Perform audits of clinical trials to ensure full compliance with regulatory requirements.
Implement any changes in practice identified from audit to improve pharmacy services to support clinical trials in conjunction with the Pharmacy Clinical Trials Manager.
7. Research and Service Development
Guide and support others undertaking research and audit.
Actively seek to improve the clinical trials service.
Undertake practice research and audit in accordance with the pharmacy research agenda.
8. Education and Training
Support the Pharmacy Clinical Trials Manager to co-ordinate clinical trial induction and Good Clinical Practice Training for the Pharmacy Department.
Develop and manage training for pharmacy, medical and non-medical staff on aspects of clinical trial management of IMPs with regard to the PCTP and SOPs.
Provide updates to Principal Investigators and other members of the research team on management of IMPs.
Participate in the training and supervision of pharmacy technicians, junior pharmacists and pre-registration pharmacy graduates identify training needs of junior staff in order to undertake their required roles.
Develop strategies to meet the training needs of staff.
Provide education and training to pharmacy and other staff.
Evaluate the training provided.
Identify own training needs and maintain a portfolio of practice.
Participate in the Departmental Education and Training Programme and ensure that a written record of Continuing Professional Development (CPD) is maintained for review at appraisal.
To act as a Practice Supervisor in line with Health Education England and Trust expectations.
9. Other Duties
Participate in education and training programmes to develop skills as part of a commitment to continuing education and the concept of lifelong learning.
Be aware of, and apply, relevant legislation such as the H & SAWA, COSHH, Medicines Act, GMP etc.
At all times practice in accordance with the Code of Ethics of the Pharmaceutical Society of Great Britain.
Act as a line manager for junior technical staff in line with departmental need.
Follow legal, ethical, professional and employers codes of conduct.
The post holder might be required to work across the Trust at any time throughout the duration of his/her contract, which may entail travel and working at different hospital sites.
Any other duties as reasonably required by the Chief Pharmacist, Associate Chief Pharmacist or Pharmacy Clinical Trials Manager.
To support the Pharmacy Clinical Trials Manager in the delivery of all clinical trials within Chelsea and Westminster Hospital NHS Trust (C&W) that have an Investigational Medicinal Product (IMP) involved in the research.
To deputise for the Pharmacy Clinical Trials Manager in their absence with relevant support from appropriate Lead Directorate Pharmacists.
To ensure that all clinical trials are carried out within the ethical and legal frameworks and meet the requirements of Good Clinical Practice (GCP), with optimal regard for documentation and patient safety.
To support the Pharmacy Clinical Trials Manager in the co-ordination and operational management of training of pharmacy staff and the research team in study specific policies and procedures.
To support delivery of the Clinical Governance Agenda in relation to medicines drug use with the Trust
To support the Pharmacy Clinical Trials Manager in the delivery of all clinical trials within Chelsea and Westminster Hospital NHS Trust (C&W) that have an Investigational Medicinal Product (IMP) involved in the research.
To deputise for the Pharmacy Clinical Trials Manager in their absence with relevant support from appropriate Lead Directorate Pharmacists.
To ensure that all clinical trials are carried out within the ethical and legal frameworks and meet the requirements of Good Clinical Practice (GCP), with optimal regard for documentation and patient safety.
To support the Pharmacy Clinical Trials Manager in the co-ordination and operational management of training of pharmacy staff and the research team in study specific policies and procedures.
To support delivery of the Clinical Governance Agenda in relation to medicines drug use with the Trust
About us
1.
Clinical Trials
To support the Pharmacy Clinical Trials Manager to lead and manage the development and delivery of specialist pharmacy services within clinical trials to ensure that;
All clinical trials that include an IMP comply with the Trust guidelines, protocols and policies and that they are set up following the Pharmacy Clinical Trials Policy (PTCP). (This includes making sure that no clinical trial can start without the appropriate approvals and are compliant with current law, regulations and policies).
Professional input is provided to the Sponsor regarding the legal procurement of IMP in line with clinical trial legislation.
The review of any contracts that exist for clinical trials where pharmacy are involved is performed when necessary. (To include Technical Agreements with any third party providers and sponsors).
An in-depth review of all Clinical Trial proposals that include IMPs is carried out as needed.
Trust policies that protect trial participants involved in clinical trials containing IMPs are continually reviewed and developed.
A specialist link between Pharmacy and the Trust R&D department exists.
Any variances in practice of clinical trials are referred to the Deputy Chief Pharmacist Clinical Support for resolution.
Liaison with the relevant Lead Directorate Pharmacists (LDPs) exits to assure:
o Sufficient resources are available to participate in any clinical trial, including technical services and dispensary leads if appropriate.
o Protocols are clinically reviewed and deemed appropriate for use within the directorate to enable sign off of the R&D form by the relevant LDP
A complete clinical trial file is maintained for each clinical trial that clearly documents all activity and processes. Key activities outlined in the PCTP include (not an exhaustive list):
v Ensuring that procurement of IMPs is legal
v Ensuring accurate documentation (receipt, issue and destruction)
v Ensuring appropriate storage of IMPs
v Ensuring that all clinical trials are archived appropriately following the PCTP.
v Ensure that the communication and service to all trial sponsors and investigators is of the highest quality
v Undertake pharmacy audits of all clinical trials involving IMPs working closely with the relevant LDPs and provide written reports of the audits to the Pharmacy Clinical Trials Manager.
v Provide appropriate assistance in emergency situations that require a code break.
Where any responsibility is delegated to an investigator (e.g. storage of an IMP in a clinical area) that the investigators are clear regarding the responsibilities they have for documentation and monitoring. Undertake spot checks on this monitoring and escalate any problems to the relevant LDP.
All relevant staff receive appropriate training and receive relevant information updates regarding the set up and procedures for all clinical trials that may impact upon them, including dispensary, buying office and stores staff.
Evidence of all systems and processes is available to the MHRA on request, including licences, ethics, R&D and Trust approvals.
Assistance is provided for any relevant inspections or audits of clinical trials e.g. MHRA, CRO or Pharmaceutical Industry and respond to the findings of any IMP recommendations, develop and implement an action plan as appropriate.
Departmental policies and SOPs relating to clinical trials are maintained and updated appropriately, in line with new guidance or legislation.
2.
Leadership
Act as a role model for all Pharmacy Technicians, junior pharmacists and pre-registration pharmacists.
Promote best practice e.g. evidence-based practice through prescription monitoring.
Deliver the clinical governance agenda in relation to medicines used within clinical trials
Follow agreed clinical governance initiatives such as incident/error reporting.
3.
Management of service
Ensure national and local agendas are delivered.
Follow and conform to relevant standards of care.
Identify and manage risks in relation to medicines use according to policy/protocol.
Delegate duties/responsibilities appropriately to other trained clinical trial staff.
Evaluate the performance of junior staff against identified criteria using departmental/Trust performance review tools and General Level Competence Framework.
4.
Clinical Practice
Participate in the checking of inpatient, outpatient, clinical trial and ward or clinic based prescriptions by undertaking the HEE LaSE Region Accredited Checking Technicians (ACPT) scheme in line with departmental policy or has previously been accredited and is now recorded on the HEE LaSE ACPT database. All ACPT technicians must demonstrate competence of practice through the GPhC Continuing Fitness to Practice and Organisational Professional Development Reviews.
Counsel patients in order to provide effective and appropriate advice to patients on medication use in order to ensure their understanding of their clinical trial medication in line with specific study protocols and pharmacy procedures, referring to appropriate members of the pharmacy and/or research team when appropriate.
Demonstrate professional accountability to patients.
Deal with queries and issues from patients and other clinical trial staff.
Effectively contend with informal / verbal complaints from research staff or patients in the first instance before appropriate referral to line manager if necessary.
Make appropriate referrals where necessary.
5. Clinical Governance
Demonstrate awareness and commitment to the Trusts Clinical Governance Agenda.
6. Evaluation of Service
Document the workload and quality of clinical trials in line with departmental and corporate objectives.
Perform audits of clinical trials to ensure full compliance with regulatory requirements.
Implement any changes in practice identified from audit to improve pharmacy services to support clinical trials in conjunction with the Pharmacy Clinical Trials Manager.
7. Research and Service Development
Guide and support others undertaking research and audit.
Actively seek to improve the clinical trials service.
Undertake practice research and audit in accordance with the pharmacy research agenda.
8. Education and Training
Support the Pharmacy Clinical Trials Manager to co-ordinate clinical trial induction and Good Clinical Practice Training for the Pharmacy Department.
Develop and manage training for pharmacy, medical and non-medical staff on aspects of clinical trial management of IMPs with regard to the PCTP and SOPs.
Provide updates to Principal Investigators and other members of the research team on management of IMPs.
Participate in the training and supervision of pharmacy technicians, junior pharmacists and pre-registration pharmacy graduates identify training needs of junior staff in order to undertake their required roles.
Develop strategies to meet the training needs of staff.
Provide education and training to pharmacy and other staff.
Evaluate the training provided.
Identify own training needs and maintain a portfolio of practice.
Participate in the Departmental Education and Training Programme and ensure that a written record of Continuing Professional Development (CPD) is maintained for review at appraisal.
To act as a Practice Supervisor in line with Health Education England and Trust expectations.
9. Other Duties
Participate in education and training programmes to develop skills as part of a commitment to continuing education and the concept of lifelong learning.
Be aware of, and apply, relevant legislation such as the H & SAWA, COSHH, Medicines Act, GMP etc.
At all times practice in accordance with the Code of Ethics of the Pharmaceutical Society of Great Britain.
Act as a line manager for junior technical staff in line with departmental need.
Follow legal, ethical, professional and employers codes of conduct.
The post holder might be required to work across the Trust at any time throughout the duration of his/her contract, which may entail travel and working at different hospital sites.
Any other duties as reasonably required by the Chief Pharmacist, Associate Chief Pharmacist or Pharmacy Clinical Trials Manager.
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