Job Summary
As a registered pharmacy technician, you will be part of the dedicated pharmacy clinical trials team providing a high quality and responsive service to patients, clinical staff, and sponsors who use our services on the QMC/City campus.
There are currently approximately 200 studies of Investigational Medicinal Products (IMPs) which are either recruiting patients or in set up ready to begin recruitment. You will be taking the technical lead in the medicines management and set up of clinical trials at NUH.
Main Duties of the Job
You must have considerable post-qualification hospital pharmacy experience, and experience of clinical trials would be an advantage.
Vital for this role are good written and verbal communication and interpersonal skills, and you must enjoy paying close attention to detail.
Your role will be central in providing a dedicated pharmacy service for clinical trial delivery through involvement with all aspects of investigational medicines management, including assisting in the set up of new studies. The role will require development and monitoring of appropriate procedures in accordance with both Good Manufacturing Practice and Good Clinical Practice as required under Clinical Trials Legislation.
Job Responsibilities
To take the lead in coordinating the technical aspects of clinical trial activities in clinical trials, ensuring compliance with standards of clinical trial management as outlined in NUH Trust Clinical Trials Policy, Guidelines for the Safe and Secure Handling of Medicines, relevant and applicable EU and UK legislation and the Research Governance Framework for Health and Social Care 2005. The post holder will be based primarily at the QMC campus but will be expected to attend meetings and work at City Campus to enhance the effectiveness of this role as appropriate. In conjunction with the Pharmacy Clinical Trial team (including specialist technicians and pharmacists), the Production Department team Quality Control and the NUH Research and Innovation department, assist in the delivery of a responsive clinical trials service, to ensure good clinical practice standards (GCP) and the needs of service users are met. With support and guidance from the Chief Technician Clinical Trials to lead on the day to day management of the clinical trials service in liaison with other Lead Clinical trial technicians. To supervise and participate in the dispensing of clinical trials prescriptions and requisitions. To supervise and participate in the accuracy checking of clinical trial prescriptions and nonclinical trial prescriptions where a pharmacist has previously professionally screened the prescription or where a professional screen is not required. To supervise and participate in the appropriate, accurate and legible completion of Investigational Medicinal Products (IMPs) and Non Investigational Medicinal Products (NIMPs) accountability documentation. To review and update clinical trial documentation and procedures in liaison with the Production Department Management team, the Pharmacy Clinical Trial team and the Quality Control Department to ensure a consistent approach. To assist the clinical trials pharmacists in the review and set-up of new clinical trials; review of amendments and updates to existing studies and dissemination to all relevant pharmacy staff to ensure compliance with protocols and procedures in line with GCP. With supervision and support from the Specialist Clinical Trials Pharmacist, take the lead on the day-to-day management of a portfolio of clinical trials from a pharmacy perspective and ensure GCP compliance on clinical trial delivery. To manage stock control of trial medicines in liaison with the Pharmacy Clinical Trial team, including ordering and receipt, monitoring of stock levels, reconciliation of returns, monitoring of expiry dates, investigation and rectification of discrepancies in accountability and ensuring appropriate storage conditions. To supervise the upkeep of dedicated clinical trial storage areas, including temperature control and monitoring. To measure and monitor all aspects of the clinical trial service on a regular basis liaising with the Information Technology and Finance administrators as needed. To assist in the induction and training of new pharmacy staff in clinical trial services and where necessary, nursing and medical research staff to ensure compliance with clinical trials protocols and procedures. To have responsibility for line managing dedicated staff, ensuring these staff are inducted appropriately and complete all necessary training. To support the Clinical Trials Finance and Admin Officer to ensure income accrued by clinical trial activity is calculated, requested and recorded according to standard procedures. To support the Principal Pharmacist Research and Innovative Treatments and the Chief Pharmacy Technician Clinical trials in preparation for and during clinical trial audit by Sponsors and MHRA inspections. To undertake project work, e.g. review of service or standards, as required providing data with which to develop the service or/and implement change as appropriate. To liaise with teams within pharmacy, the NUH Trust Research and Innovation Directorate and other NHS Trusts, and trial investigators, when necessary and appropriate. To host sponsors representatives during their visits to the clinical trials department. To oversee and support the study close down and the archiving of essential trial documentation in line with national guidance. To undertake a regular operational commitment in the in-patient dispensary/satellites within NUH to maintain competencies and demonstrate fitness to practice as a registered pharmacy technician.
General Duties
To participate as an appraiser and appraisee in the departmental individual professional development review. To participate in departmental weekend, bank holiday and late duty working as required. To participate in the interviewing and selection of new staff for the Pharmacy department. To adhere to all relevant legislation and Trust policies. To be accountable for own professional practice at all times. To maintain confidentiality in all work areas. To undertake annual mandatory training. To undertake any other duties that may reasonably be required as agreed with senior staff.
Person Specification
Training and Qualifications
Essential BTEC, City and Guilds or NVQ level 3 in Pharmaceutical Services, or recognised equivalent. Registered pharmacy technician with the General Pharmaceutical Council (GPhC). Desirable Existing management and organisational skills. Qualified Accuracy Checker. Experience
Essential Clear understanding of the role of the technician in clinical trials management. Extensive and varied experience of working in hospital pharmacy. Desirable Experience in pharmacy clinical trials services. Communication and Relationship Skills
Essential Good verbal, written and interpersonal skills. Analytical and Judgement Skills
Essential Accurate and logical with excellent attention to detail. Able to interpret complex trial protocols. Planning and Organisation Skills
Essential Methodical with good organisational skills and good time management. Able to oversee more than one task at a time.
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As a registered pharmacy technician, you will be part of the dedicated pharmacy clinical trials team providing a high quality and responsive service to patients, clinical staff, and sponsors who use our services on the QMC/City campus.
There are currently approximately 200 studies of Investigational Medicinal Products (IMPs) which are either recruiting patients or in set up ready to begin recruitment. You will be taking the technical lead in the medicines management and set up of clinical trials at NUH.
Main Duties of the Job
You must have considerable post-qualification hospital pharmacy experience, and experience of clinical trials would be an advantage.
Vital for this role are good written and verbal communication and interpersonal skills, and you must enjoy paying close attention to detail.
Your role will be central in providing a dedicated pharmacy service for clinical trial delivery through involvement with all aspects of investigational medicines management, including assisting in the set up of new studies. The role will require development and monitoring of appropriate procedures in accordance with both Good Manufacturing Practice and Good Clinical Practice as required under Clinical Trials Legislation.
Job Responsibilities
To take the lead in coordinating the technical aspects of clinical trial activities in clinical trials, ensuring compliance with standards of clinical trial management as outlined in NUH Trust Clinical Trials Policy, Guidelines for the Safe and Secure Handling of Medicines, relevant and applicable EU and UK legislation and the Research Governance Framework for Health and Social Care 2005. The post holder will be based primarily at the QMC campus but will be expected to attend meetings and work at City Campus to enhance the effectiveness of this role as appropriate. In conjunction with the Pharmacy Clinical Trial team (including specialist technicians and pharmacists), the Production Department team Quality Control and the NUH Research and Innovation department, assist in the delivery of a responsive clinical trials service, to ensure good clinical practice standards (GCP) and the needs of service users are met. With support and guidance from the Chief Technician Clinical Trials to lead on the day to day management of the clinical trials service in liaison with other Lead Clinical trial technicians. To supervise and participate in the dispensing of clinical trials prescriptions and requisitions. To supervise and participate in the accuracy checking of clinical trial prescriptions and nonclinical trial prescriptions where a pharmacist has previously professionally screened the prescription or where a professional screen is not required. To supervise and participate in the appropriate, accurate and legible completion of Investigational Medicinal Products (IMPs) and Non Investigational Medicinal Products (NIMPs) accountability documentation. To review and update clinical trial documentation and procedures in liaison with the Production Department Management team, the Pharmacy Clinical Trial team and the Quality Control Department to ensure a consistent approach. To assist the clinical trials pharmacists in the review and set-up of new clinical trials; review of amendments and updates to existing studies and dissemination to all relevant pharmacy staff to ensure compliance with protocols and procedures in line with GCP. With supervision and support from the Specialist Clinical Trials Pharmacist, take the lead on the day-to-day management of a portfolio of clinical trials from a pharmacy perspective and ensure GCP compliance on clinical trial delivery. To manage stock control of trial medicines in liaison with the Pharmacy Clinical Trial team, including ordering and receipt, monitoring of stock levels, reconciliation of returns, monitoring of expiry dates, investigation and rectification of discrepancies in accountability and ensuring appropriate storage conditions. To supervise the upkeep of dedicated clinical trial storage areas, including temperature control and monitoring. To measure and monitor all aspects of the clinical trial service on a regular basis liaising with the Information Technology and Finance administrators as needed. To assist in the induction and training of new pharmacy staff in clinical trial services and where necessary, nursing and medical research staff to ensure compliance with clinical trials protocols and procedures. To have responsibility for line managing dedicated staff, ensuring these staff are inducted appropriately and complete all necessary training. To support the Clinical Trials Finance and Admin Officer to ensure income accrued by clinical trial activity is calculated, requested and recorded according to standard procedures. To support the Principal Pharmacist Research and Innovative Treatments and the Chief Pharmacy Technician Clinical trials in preparation for and during clinical trial audit by Sponsors and MHRA inspections. To undertake project work, e.g. review of service or standards, as required providing data with which to develop the service or/and implement change as appropriate. To liaise with teams within pharmacy, the NUH Trust Research and Innovation Directorate and other NHS Trusts, and trial investigators, when necessary and appropriate. To host sponsors representatives during their visits to the clinical trials department. To oversee and support the study close down and the archiving of essential trial documentation in line with national guidance. To undertake a regular operational commitment in the in-patient dispensary/satellites within NUH to maintain competencies and demonstrate fitness to practice as a registered pharmacy technician.
General Duties
To participate as an appraiser and appraisee in the departmental individual professional development review. To participate in departmental weekend, bank holiday and late duty working as required. To participate in the interviewing and selection of new staff for the Pharmacy department. To adhere to all relevant legislation and Trust policies. To be accountable for own professional practice at all times. To maintain confidentiality in all work areas. To undertake annual mandatory training. To undertake any other duties that may reasonably be required as agreed with senior staff.
Person Specification
Training and Qualifications
Essential BTEC, City and Guilds or NVQ level 3 in Pharmaceutical Services, or recognised equivalent. Registered pharmacy technician with the General Pharmaceutical Council (GPhC). Desirable Existing management and organisational skills. Qualified Accuracy Checker. Experience
Essential Clear understanding of the role of the technician in clinical trials management. Extensive and varied experience of working in hospital pharmacy. Desirable Experience in pharmacy clinical trials services. Communication and Relationship Skills
Essential Good verbal, written and interpersonal skills. Analytical and Judgement Skills
Essential Accurate and logical with excellent attention to detail. Able to interpret complex trial protocols. Planning and Organisation Skills
Essential Methodical with good organisational skills and good time management. Able to oversee more than one task at a time.
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