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This job advert has expired and applications have closed.
Principal Trial Coordinator - Head of Amendments and GCP- QA
| Posting date: | 03 March 2025 |
|---|---|
| Salary: | Not specified |
| Additional salary information: | £44,806 - £53,134 per annum incl. HCA |
| Hours: | Full time |
| Closing date: | 17 April 2025 |
| Location: | London, SE1 9RT |
| Company: | Guys and St Thomas NHS Foundation Trust |
| Job type: | Permanent |
| Job reference: | 7023475/196-LIS9378 |
Summary
A Vacancy at Guy's and St Thomas' NHS Foundation Trust.
This is an exciting opportunity to join our Clinical Trials (Adult) Pharmacy Department. The department manages, between two sites (Guy’s Hospital and St Thomas’ Hospital), a portfolio of over 900 Clinical Trials ranging from early stage Phase I studies to Post license Phase IV studies; handling a multicohort of molecules from Advanced Therapies to traditional investigational medicinal formulations. The successful applicant will be working alongside industry leading clinical researchers within GSTT and from abroad on set up and management of clinical Trials at site level.
Study Amendments
To undertake following activities and / or responsibilities linked to Pharmacy Clinical Trials Amendment Processing at site level:
1. Act as an Accountable Person on managing Pharmacy Amendments
2. Receive, organise, process and manage a portfolio of Clinical Trials Amendment Notifications in a systematic way using agreed quality systems such as Amendment Tracker incorporated with various data sets
3. Liaise with Amendments Central Coordinating Team based at GSTT R&D and King’s Health Partners’ Clinical Trials Office (KHP-CTO), and undertake amendment related activities.
4. Escalate and discuss complex Amendment matters that requires expert attention, to Highly Specialist Clinical Trials Pharmacist and / or other delegated CT Pharmacists
5. Periodically review internal Amendment processes and procedures in order to optimise them to achieve performance, regulatory compliance and meet HRA targets
6. Undertake periodical internal Audits of Amendment processes and its GCP compliance within the Pharmacy Clinical Trials Department
GCP: – Operations, Quality and Assurance
Ensure all staff members who works for Pharmacy Clinical Trials (CT) department are up to date with their GCP certification.
Guy’s & St Thomas NHS Foundation Trust
Guy’s and St Thomas’ NHS Foundation Trust comprises five of the UK’s best-known hospitals – Guy’s, St Thomas’, Evelina London Children’s Hospital, Royal Brompton and Harefield.
About our Research and Development
The R&D Department at Guy’s & St Thomas’ NHS Foundation Trust (GSTFT) is one of the focal points for innovative research in London through its nationally recognised research portfolio and research infrastructure. We are systems leaders in NHS research with strong strategic partnerships across the National Institute for Health Research (NIHR), Department of Health & Social Care (DHSC) and the Health Research Authority (HRA) and are active members of the organisations such as the Shelford Group, University Hospitals Association (previously AUKUH) and UKRD. Research is a top priority for the Trust which in 2021/22 was the top NHS organisation nationally for the number of NIHR portfolio studies open (417) and was the top recruiting organisation in South London (third nationally) recruiting over 19,000 participants into NIHR portfolio studies.
Our research infrastructure includes our NIHR Clinical Research Facility (CRF) located St Thomas’ Hospital, Guy’s Hospital, Evelina London Children’s Hospital and the Royal Brompton Hospital; the Guy’s Phase I unit is an MHRA Accredited Phase I Unit.
2. KEY RESPONSIBILITIES
Study Amendments
To undertake following activities and / or responsibilities linked to Pharmacy Clinical Trials Amendment Processing at site level:
1. Act as an Accountable Person on managing Pharmacy Amendments
2. Receive, organise, process and manage a portfolio of Clinical Trials Amendment Notifications in a systematic way using agreed quality systems such as Amendment Tracker incorporated with various data sets
3. Liaise with Amendments Central Coordinating Team based at GSTT R&D and King’s Health Partners’ Clinical Trials Office (KHP-CTO), and undertake following activities:
a. On Pharmacy Amendment matters, act as a liaison and interface between R&D, KHP-CTO, Sponsor and various pharmacy support departments
b. Manage Pharmacy Amendment Email Inbox
c. Receive and systematically stratify various Amendments notifications based on its HRA classification and priority
d. Demonstrate objective and solution focused advanced communication skills when engaging with key stakeholders
e. Manage ‘Clinical Trials Amendment Tracker’ in a systematic way optimising system function and quality of data
f. Undertake majority of Amendments’ review, approval and Implementation. In due process, liaise with designated / delegated Pharmacy Technicians and / or Pharmacists for support, completion and quality assurance
4. Escalate and discuss complex Amendment matters that requires expert attention, to Highly Specialist Clinical Trials Pharmacist and / or other delegated CT Pharmacists
5. Periodically review internal Amendment processes and procedures in order to optimise them to achieve performance, regulatory compliance and meet HRA targets
6. Undertake periodical internal Audits of Amendment processes and its GCP compliance within the Pharmacy Clinical Trials Department
GCP: – Operations, Quality and Assurance
To undertake following activities and / or responsibilities linked to Pharmacy Clinical Trials Operations and Quality of Service
Ensure all staff members who works for Pharmacy Clinical Trials (CT) department are up to date with their GCP certification
On day to day operational matters of the department, advise CT staff on GCP components to adhere
Advise CT staff on Investigational Medicinal Products compliance matters such as faulty IMPs, internal IMP storage failures, product recalls, quarantined stock, Monitoring Visits (MV) follow up reports and on a wide range of quality matters
Identify existing and emerging risks that may undermine department’s quality systems and consequently Patients’ / Subjects’ safety
Periodically review and amend department’s Standard Operating Procedures and ensure staff compliance to it.
Deputise Highly Specialist Pharmacist in GSTT governance committees such as R&D Risk and Governance Committee, Pharmacy Incidents Review Committee and various Trial Management Groups (TMGs)
Organise and provide quality components that are relevant to Site Qualification Visits (SQV), Sponsor Pharmacy support, Monitoring Visits and Site Initiation Visits (SIV)
Provide general oversight of operations to ensure quality of the service is always upheld and patient safety is paramount.
Facilities and Equipment
To undertake following activities and / or responsibilities linked to Pharmacy Clinical Trials Amendment Processing at site level:
The CT department manages a portfolio of IMP storage equipment ranging from untra-low temperature freezers to standard room temperature-controlled rooms where IMPs are stored. The post holder will accountable person and overall in-charge of ensuring yearly maintenance of these equipment and units, and obtaining calibration certificates from GSTT contractors.
Ensure all temperature monitoring devices are calibrated yearly
Store and maintain key facility and equipment document for compliance, audits and inspections
Undertake Capacity assessment of IMP storage systems. Periodically review and asses risks to the service delivery against capacity constraints
Liaise with GSTT Medical Equipment department on commissioning new equipment
Undertake validation and commissioning new facilities and equipment
Undertake risk assessment in areas that are external to the department where IMPs are stored
Training: Amendments, GCP-Quality
To undertake following activities and / or responsibilities linked to Pharmacy Clinical Trials staff training:
Ensure all staff members who works for Pharmacy Clinical Trials (CT) department are up to date with their GCP certification
Draft training materials on various GCP components for the purpose of departmental training
Co-ordinate annual refresher training and document it appropriately
Deliver training to the CT staff focusing on Amendment Processing. Ensure all delegated staff members are competent in processing amendments
Identity and remedy GCP non-compliance with regards to Amendment processing through systematic training
Support Principal Technician on induction of new staff members and yearly Performance Development Review (PDR)
Comply with GSTT mandatory training requirements
Comply with all professional requirements set out by the relevant regulatory and professional bodies
Incidents, Risks Management Systems and Learning
To undertake following activities and / or responsibilities linked to Pharmacy Clinical Trials Incidents, Risks and Learning from mistakes:
Act as a Responsible Person for managing Incidents originated from the CT department: – process them in accordance with policies of the CT department, R&D and GSTT
Engage with R&D Risks and Governance Committee on Incidents reporting, formulating corrective actions and implementing corrective and preventative actions
Engage with Pharmacy Incidents Review Committee and manage incidents originated from the CT Department, in line with Trust’s Guidelines
Create and implement risk remedying measures. Optimise Department’s performance on safety and sustainability
Generate learnings from incidents and incorporate it in the training materials and general practice
Participate in relevant Trainings offered by internal and external stakeholders
Audits and Inspections & Governance
To undertake following activities and / or responsibilities linked to Pharmacy Clinical Trials Audits and Inspections:
Liaise with R&D Quality Department on GSTT R&D specific Audit and inspection matters. Support them with required pharmacy components that essential for facing audits and post audit follow up actions
Liaise with various Clinical Research Directorates on Audit matters:
• prepare for external Audits and Inspections by ensuring Pharmacy GCP standards are assured
• Act as an accountable person for Department’s Audit and Inspection readiness
• Co-ordinate resources during Audit and Inspections
• Following Audits and Inspections, formulate Corrective and Preventative Actions (CAPA) as per the findings, and implement them within the agreed time window
• Sustain and monitor Preventative Actions (PA) by ensuring periodical internal audits are conducted
• Undertake relevant regulatory specific training and knowledge upscaling in order to be resilient on adversities
• Report any relevant concerns to the Highly Specialist Clinical Trials Pharmacist and R&D Quality Lead in a timely fashion.
4. KEY RELATIONSHIPS
The post holder will be in regular contact with staff within Guy’s & St Thomas’ Trust and outside organisations/agencies. This will include the following and their support staff:
Internal:
• All Trust staff undertaking research (clinical and non-clinical)
• Trust R&D Leads
• Trust R&D Quality Lead
• NIHR hosted platform and Local RDN
• Directorate R&D Groups
• R&D Finance Department
• KHP CTO Directorates
• GMP
• Pharmacy Manufacturing
• General Pharmacy and its administrative wings
• Other Clinical Trials Work Streams
• Various Pharmacy Clinical Directors and General Managers
External:
• King’s College London
• KHP partners: Evelina Hospitals, SLAM, RBH and King’s College Hospital and Lewisham Hospital
• NIHR
• HRA
• Sponsors and Chief Investigators
• IMP Manufacturing, QP and Import contractors
5. KNOWLEDGE, SKILLS AND COMPETENCY:
The post holder is expected to possess in-depth specialist knowledge in fundamentals of Clinical Trials Pharmacy Operations and should be competent in demonstrating skill sets that are essential to meet the requirements of this Job Role. The post holder will be required to analyse, and make definite judgements and interpretations (independently) on information embed in the key study documents which will be highly complex and complicated. This information will need to be received and communicated effectively. This may involve producing reports and analysing complex data which will require prolonged concentration.
Negotiation skills will be key when dealing with contentious viewpoints and unclear / conflicting information.
To establish and develop good working relationships with each of the CT Pharmacy Leads and Trust R&D Leads,
To develop and maintain an up-to-date understanding of the requirements of the UK Policy Framework for Health and Social Care
Research, and the governance issues and requirements in relation to the Research Ethics Committees for the NHS, in order to provide advice to researchers with research governance queries.
To establish and undertake a proactive systematic programme for pharmacy research governance and its monitoring
To lead on presentations/training to researchers and pharmacy staff in relation to pharmacy approvals, set up and study management
This job description provides an outline of some of the duties you will be required to perform, however these duties may be changed or expanded in line with the needs of the Research & Development Office and the Medical Director’s Office.
This advert closes on Tuesday 1 Apr 2025
This is an exciting opportunity to join our Clinical Trials (Adult) Pharmacy Department. The department manages, between two sites (Guy’s Hospital and St Thomas’ Hospital), a portfolio of over 900 Clinical Trials ranging from early stage Phase I studies to Post license Phase IV studies; handling a multicohort of molecules from Advanced Therapies to traditional investigational medicinal formulations. The successful applicant will be working alongside industry leading clinical researchers within GSTT and from abroad on set up and management of clinical Trials at site level.
Study Amendments
To undertake following activities and / or responsibilities linked to Pharmacy Clinical Trials Amendment Processing at site level:
1. Act as an Accountable Person on managing Pharmacy Amendments
2. Receive, organise, process and manage a portfolio of Clinical Trials Amendment Notifications in a systematic way using agreed quality systems such as Amendment Tracker incorporated with various data sets
3. Liaise with Amendments Central Coordinating Team based at GSTT R&D and King’s Health Partners’ Clinical Trials Office (KHP-CTO), and undertake amendment related activities.
4. Escalate and discuss complex Amendment matters that requires expert attention, to Highly Specialist Clinical Trials Pharmacist and / or other delegated CT Pharmacists
5. Periodically review internal Amendment processes and procedures in order to optimise them to achieve performance, regulatory compliance and meet HRA targets
6. Undertake periodical internal Audits of Amendment processes and its GCP compliance within the Pharmacy Clinical Trials Department
GCP: – Operations, Quality and Assurance
Ensure all staff members who works for Pharmacy Clinical Trials (CT) department are up to date with their GCP certification.
Guy’s & St Thomas NHS Foundation Trust
Guy’s and St Thomas’ NHS Foundation Trust comprises five of the UK’s best-known hospitals – Guy’s, St Thomas’, Evelina London Children’s Hospital, Royal Brompton and Harefield.
About our Research and Development
The R&D Department at Guy’s & St Thomas’ NHS Foundation Trust (GSTFT) is one of the focal points for innovative research in London through its nationally recognised research portfolio and research infrastructure. We are systems leaders in NHS research with strong strategic partnerships across the National Institute for Health Research (NIHR), Department of Health & Social Care (DHSC) and the Health Research Authority (HRA) and are active members of the organisations such as the Shelford Group, University Hospitals Association (previously AUKUH) and UKRD. Research is a top priority for the Trust which in 2021/22 was the top NHS organisation nationally for the number of NIHR portfolio studies open (417) and was the top recruiting organisation in South London (third nationally) recruiting over 19,000 participants into NIHR portfolio studies.
Our research infrastructure includes our NIHR Clinical Research Facility (CRF) located St Thomas’ Hospital, Guy’s Hospital, Evelina London Children’s Hospital and the Royal Brompton Hospital; the Guy’s Phase I unit is an MHRA Accredited Phase I Unit.
2. KEY RESPONSIBILITIES
Study Amendments
To undertake following activities and / or responsibilities linked to Pharmacy Clinical Trials Amendment Processing at site level:
1. Act as an Accountable Person on managing Pharmacy Amendments
2. Receive, organise, process and manage a portfolio of Clinical Trials Amendment Notifications in a systematic way using agreed quality systems such as Amendment Tracker incorporated with various data sets
3. Liaise with Amendments Central Coordinating Team based at GSTT R&D and King’s Health Partners’ Clinical Trials Office (KHP-CTO), and undertake following activities:
a. On Pharmacy Amendment matters, act as a liaison and interface between R&D, KHP-CTO, Sponsor and various pharmacy support departments
b. Manage Pharmacy Amendment Email Inbox
c. Receive and systematically stratify various Amendments notifications based on its HRA classification and priority
d. Demonstrate objective and solution focused advanced communication skills when engaging with key stakeholders
e. Manage ‘Clinical Trials Amendment Tracker’ in a systematic way optimising system function and quality of data
f. Undertake majority of Amendments’ review, approval and Implementation. In due process, liaise with designated / delegated Pharmacy Technicians and / or Pharmacists for support, completion and quality assurance
4. Escalate and discuss complex Amendment matters that requires expert attention, to Highly Specialist Clinical Trials Pharmacist and / or other delegated CT Pharmacists
5. Periodically review internal Amendment processes and procedures in order to optimise them to achieve performance, regulatory compliance and meet HRA targets
6. Undertake periodical internal Audits of Amendment processes and its GCP compliance within the Pharmacy Clinical Trials Department
GCP: – Operations, Quality and Assurance
To undertake following activities and / or responsibilities linked to Pharmacy Clinical Trials Operations and Quality of Service
Ensure all staff members who works for Pharmacy Clinical Trials (CT) department are up to date with their GCP certification
On day to day operational matters of the department, advise CT staff on GCP components to adhere
Advise CT staff on Investigational Medicinal Products compliance matters such as faulty IMPs, internal IMP storage failures, product recalls, quarantined stock, Monitoring Visits (MV) follow up reports and on a wide range of quality matters
Identify existing and emerging risks that may undermine department’s quality systems and consequently Patients’ / Subjects’ safety
Periodically review and amend department’s Standard Operating Procedures and ensure staff compliance to it.
Deputise Highly Specialist Pharmacist in GSTT governance committees such as R&D Risk and Governance Committee, Pharmacy Incidents Review Committee and various Trial Management Groups (TMGs)
Organise and provide quality components that are relevant to Site Qualification Visits (SQV), Sponsor Pharmacy support, Monitoring Visits and Site Initiation Visits (SIV)
Provide general oversight of operations to ensure quality of the service is always upheld and patient safety is paramount.
Facilities and Equipment
To undertake following activities and / or responsibilities linked to Pharmacy Clinical Trials Amendment Processing at site level:
The CT department manages a portfolio of IMP storage equipment ranging from untra-low temperature freezers to standard room temperature-controlled rooms where IMPs are stored. The post holder will accountable person and overall in-charge of ensuring yearly maintenance of these equipment and units, and obtaining calibration certificates from GSTT contractors.
Ensure all temperature monitoring devices are calibrated yearly
Store and maintain key facility and equipment document for compliance, audits and inspections
Undertake Capacity assessment of IMP storage systems. Periodically review and asses risks to the service delivery against capacity constraints
Liaise with GSTT Medical Equipment department on commissioning new equipment
Undertake validation and commissioning new facilities and equipment
Undertake risk assessment in areas that are external to the department where IMPs are stored
Training: Amendments, GCP-Quality
To undertake following activities and / or responsibilities linked to Pharmacy Clinical Trials staff training:
Ensure all staff members who works for Pharmacy Clinical Trials (CT) department are up to date with their GCP certification
Draft training materials on various GCP components for the purpose of departmental training
Co-ordinate annual refresher training and document it appropriately
Deliver training to the CT staff focusing on Amendment Processing. Ensure all delegated staff members are competent in processing amendments
Identity and remedy GCP non-compliance with regards to Amendment processing through systematic training
Support Principal Technician on induction of new staff members and yearly Performance Development Review (PDR)
Comply with GSTT mandatory training requirements
Comply with all professional requirements set out by the relevant regulatory and professional bodies
Incidents, Risks Management Systems and Learning
To undertake following activities and / or responsibilities linked to Pharmacy Clinical Trials Incidents, Risks and Learning from mistakes:
Act as a Responsible Person for managing Incidents originated from the CT department: – process them in accordance with policies of the CT department, R&D and GSTT
Engage with R&D Risks and Governance Committee on Incidents reporting, formulating corrective actions and implementing corrective and preventative actions
Engage with Pharmacy Incidents Review Committee and manage incidents originated from the CT Department, in line with Trust’s Guidelines
Create and implement risk remedying measures. Optimise Department’s performance on safety and sustainability
Generate learnings from incidents and incorporate it in the training materials and general practice
Participate in relevant Trainings offered by internal and external stakeholders
Audits and Inspections & Governance
To undertake following activities and / or responsibilities linked to Pharmacy Clinical Trials Audits and Inspections:
Liaise with R&D Quality Department on GSTT R&D specific Audit and inspection matters. Support them with required pharmacy components that essential for facing audits and post audit follow up actions
Liaise with various Clinical Research Directorates on Audit matters:
• prepare for external Audits and Inspections by ensuring Pharmacy GCP standards are assured
• Act as an accountable person for Department’s Audit and Inspection readiness
• Co-ordinate resources during Audit and Inspections
• Following Audits and Inspections, formulate Corrective and Preventative Actions (CAPA) as per the findings, and implement them within the agreed time window
• Sustain and monitor Preventative Actions (PA) by ensuring periodical internal audits are conducted
• Undertake relevant regulatory specific training and knowledge upscaling in order to be resilient on adversities
• Report any relevant concerns to the Highly Specialist Clinical Trials Pharmacist and R&D Quality Lead in a timely fashion.
4. KEY RELATIONSHIPS
The post holder will be in regular contact with staff within Guy’s & St Thomas’ Trust and outside organisations/agencies. This will include the following and their support staff:
Internal:
• All Trust staff undertaking research (clinical and non-clinical)
• Trust R&D Leads
• Trust R&D Quality Lead
• NIHR hosted platform and Local RDN
• Directorate R&D Groups
• R&D Finance Department
• KHP CTO Directorates
• GMP
• Pharmacy Manufacturing
• General Pharmacy and its administrative wings
• Other Clinical Trials Work Streams
• Various Pharmacy Clinical Directors and General Managers
External:
• King’s College London
• KHP partners: Evelina Hospitals, SLAM, RBH and King’s College Hospital and Lewisham Hospital
• NIHR
• HRA
• Sponsors and Chief Investigators
• IMP Manufacturing, QP and Import contractors
5. KNOWLEDGE, SKILLS AND COMPETENCY:
The post holder is expected to possess in-depth specialist knowledge in fundamentals of Clinical Trials Pharmacy Operations and should be competent in demonstrating skill sets that are essential to meet the requirements of this Job Role. The post holder will be required to analyse, and make definite judgements and interpretations (independently) on information embed in the key study documents which will be highly complex and complicated. This information will need to be received and communicated effectively. This may involve producing reports and analysing complex data which will require prolonged concentration.
Negotiation skills will be key when dealing with contentious viewpoints and unclear / conflicting information.
To establish and develop good working relationships with each of the CT Pharmacy Leads and Trust R&D Leads,
To develop and maintain an up-to-date understanding of the requirements of the UK Policy Framework for Health and Social Care
Research, and the governance issues and requirements in relation to the Research Ethics Committees for the NHS, in order to provide advice to researchers with research governance queries.
To establish and undertake a proactive systematic programme for pharmacy research governance and its monitoring
To lead on presentations/training to researchers and pharmacy staff in relation to pharmacy approvals, set up and study management
This job description provides an outline of some of the duties you will be required to perform, however these duties may be changed or expanded in line with the needs of the Research & Development Office and the Medical Director’s Office.
This advert closes on Tuesday 1 Apr 2025