Specialist Clinical Trials Pharmacist - Infectious Diseases/COVID

Job content

To deliver, sustain, evaluate and further develop our Clinical Trials Operations that meet the service demands and researchstandards at Guy’s and St. Thomas’ NHS Foundation Trust.

By working cross-site between Guy’s and St. Thomas’ hospitals Pharmacy Clinical Trials Department, the post holder will be working alongside the Highly Specialist Pharmacist to oversee operations of all our Infectious Disease studies and other studies. As part of the daily operations, the post holder will be actively engaging with R&D, various Principal Investigators, Research Leads and Sponsors in order to ensure studies are run within the principle of GCP and ICH guidelines.

The post holder will be an integral part of rolling out new studies from the early stage of pre-site qualifications through the site selection, study set-up, opening and study management throughout its cycle.

By working collaboratively along with other Specialist Pharmacists, Principal Technician, Trial Technicians and colleagues from various research platforms, the post holder will be supporting a complex web of trial operations that are structured objectively to meet the research goals of R&D and KHP CTO units.

Guy’s and St Thomas’ is among the UK’s busiest and most successful NHS foundation trusts. We provide a full range of hospital and community services for people in south London and as well as specialist care for patients from further afield including cancer, renal, orthopaedic, respiratory and cardiovascular services. Guy’s is home to the largest dental school in Europe and a £160 million Cancer Centre opened in 2016.

Evelina London cares for local children in Lambeth and Southwark and provides specialist services across south east England including cardiac, renal and critical care services. We lead a number of specialist service networks aiming to ensure children are treated locally where possible, but have access to specialist expertise when they need it.

In February 2021 the Royal Brompton and Harefield joined Guy’s and St Thomas’ NHS Foundation Trust, bringing together world-leading expertise in the care and research of heart and lung disease.

We are part of King’s Health Partners, one of eight accredited UK academic health sciences centres. In partnership with King’s College London we have dedicated clinical research facilities and a National Institute for Health Research (NIHR) Biomedical Research Centre.

Following a comprehensive Care Quality Commission (CQC) inspection in 2019 we maintained our overall rating of ‘good’. Our adult community services achieved a rating of ‘outstanding’.

Duties and Responsibilities

Compliance with Good Clinical Practice (GCP) principles and other ICH guidelines

• The post holder must have good insight of GCP principles and ICH guidelines, and be able to apply it all the time when undertaking study related tasks. When dealing with any aspects of a Clinical Trial, the application of GCP principles must be up to date, consistent, reproducible, prudent and aimed to ensure optimum patient safety
• The post holder must ensure, his/her GCP certification is valid and up to date
• In readiness for internal or external audits, the post holder bear the responsibility to ensure department’s GCP elements are checked and any shortfalls identified are rectified

Compliance with Regulatory Guidelines

• The post holder must be fluent and up-to-date with all concerned regulatory guidelines issued periodically by MHRA, ICH, GMP and be able to apply them appropriately whenever necessary.
• The post holder should always adhere to the GPHC’s professional standards

Operational responsibilities

• The post holder will be rostered to run day to day operations of the Clinical Trials Services across Guy’s and St. Thomas’ Hospitals. This includes checking clinical trial prescriptions, releasing IMPs, assisting sponsors’ monitoring visits, attending Site Initiating Visits, scheduling work flow, organising meetings with various research partners and directing clinical trials personnel in managing the workload
• To deputise the Highly Specialist Clinical Trials Pharmacist in various research and governance meetings whenever necessary
• To conduct local feasibility reviews of new studies and issue various approval
• To set up new studies to a high quality GCP standards and issue greenlight on time meeting key NIHR timelines
• To demonstrate expert knowledge of managing, mitigating and preventing risks when conducting Phase I, II, III, and IV studies
• To collaborate with other clinical trial support platforms, departments within the pharmacy and externally as part of setting-up new studies (e.g. Aseptic Production Unit, GMP, Pharmacy manufacturing Unit (PMU))
• To assist R&D and KHP CTO partners in providing relevant information to assist site selection, study set-up and study management
• To respond to study amendments by reviewing it, issuing pharmacy approval and implementing pharmacy specific actions once a full Trust approval is obtained
• To conduct audits periodically on internally and externally managed IMPs and/or studies
• To demonstrate, on a daily basis, advanced knowledge of clinical pharmacy skills in order to ensure Clinical Trials Prescriptions are screened to the optimum clinical standards
• To apply critical thinking, sound clinical reasoning and judgement when dealing with Clinical Trials prescriptions and governance matters
• The post holder should always ensure that the policies, guidelines and values of the Trust are upheld, and demonstrate commitment to the Trust’s Clinical Governance Agenda
• Be professionally accountable for the conduct of all of the department and self
• Assist Highly Specialist Clinical Trails Pharmacist in implementing quality and patient safety improvement initiatives
• Be flexible to work across both sites (Guy’s and St. Thomas’ Hospitals) in response to the demands of the Clinical Trial Services

Communication

• The post holder will be expected to demonstrate advanced level of communication skills at all time
• The operational nature of the Clinical Trial Service demands complex internal and external communications, both verbally and in writing. It is the responsibility of the post holder to ensure these communications are objectively responded by applying advanced communications skills
• To demonstrate timely communication within the department to ensure execution of operations on time
• Be able to escalate concerns and challenges by applying advanced communication skills
• Communicate with confidence, reasoning and openness
• Encourage building open channels of communication between colleagues and partners

Leadership

• Support Highly Specialist Clinical Trials Pharmacist in developing and implementing services that are integral to the clinical trials department and pertinent to the broader pharmacy services
• Provide leadership and guidance to other Clinical Trial colleagues on setting-up new studies and managing existing studies
• Lead the department in the absence of Highly Specialist Clinical Trial Pharmacist
• Take appropriate decisions when dealing with Clinical Trials operational matters in the absence of Highly Specialist Clinical Trial Pharmacist
• Consult with seniors, if necessary, when dealing with professional or operational matters
• Provide support and leadership for quality improvement projects that are initiated periodically
• To be innovative and pragmatic when dealing with complex situations

Quality, evaluation and sustainability of the Service

• To review, reflect and act on internal/external audit reports in line with GCP principles and Trust’s R&D standards
• To support Highly Specialist Pharmacist in populating, analysing and presenting data on Clinical Trial Service’s performance for the purpose of NHS benchmarking
• To identify and promote best practices in Clinical Research
• To assist the R&D and other research teams to comply with the quality standards of the Trust
• As the Clinical Trials Service is funded by the NIHR–LCRN, periodically they seek information on operations and study numbers; post holder should assist them with providing this information
• To respond by investigating incidents reported on DATIX or internally and take the appropriate measures to prevent them from happening again
• Formulate Corrective actions and Preventative Actions (CAPA) in response to incidents related to Clinical Trials and share it with sponsors in a timely manner
• To be aware of the need of identifying, reporting (using DATIX system) and recording major risks in the departmental Risk Register in line with Trust Guidelines
• To formulate and review standard operating procedures (SOPs) to support operations and governance of the department
• To collaborate with other Pharmacists and Research Partners who works under the King’s Health Partners (KHP), the overarching organisation, under which the GSTT operates
• To support KHP partners on developing and reviewing common operational and quality related SOPs

Education and Training

• To support Highly Specialist Pharmacist in achieving full compliance with Trust’s mandatory training requirements
• To train new Rotational Pharmacists on Clinical Trial prescription screening, IMP checking, IMP releasing and Pharmacy Site Folder management to ensure GCP compliance
• To support induction of Specialist Pharmacists, Pre-Registration Pharmacists, student Technicians and Administrative staff
• To identify, develop and implement new training programmes for Clinical Trials staff; principally in response to new studies, new therapies such as Advanced Therapies, changes to relevant regulatory landscape and in the interest of scientific advancement
• To develop strategies on delivering training to internal and external staff. Examples includes setting up online training programmes, collaborating with R&D’s Training and Workforce department in order to create pharmacy specific training modules on the Trust’s R&D training web platform
• To be a named tutor/mentor to junior members of pharmacy staff, including undertaking formal evaluations of their progress
• To demonstrate a commitment to continuing education and the concept of lifelong learning
• To maintain a log of education and training activities undertaken
• To give feedback to the wider team following attending learning events

Collaborate and support Research and Development (R&D)

The post holder will actively collaborate with R&D on various fronts:

• On setting up and managing non-commercial studies by liaising with R&D’s various operational and service delivery vehicles
• On occasions deputising the Senior Specialist Pharmacist in the R&D governance and operational meetings
• On disseminating R&D’s research strategies and objectives to the Clinical Trials Pharmacy Team, and supporting the team to achieve these goals
• On obtaining key pharmacy specific Trial data for the analysis of operational performance
• On achieving key timelines of new study set up as set out in the collaborative frameworks Pharmacy agreed with various research directorates
• On supporting the R&D by providing resource and capacity data in order for them to formulate business plan

Management of Clinical Trials Pharmacy

The post holder will be:

• Managing day to day operations of the Clinical Trials Pharmacy by working along with the Rotational Pharmacist and Technical team in order to clear the IMP dispensing, checking and release
• Planning, organising and supporting study monitors (MVs)
• Planning and attending Study Initiation Visits (SIVs)
• Planning and accommodating Site Qualifications Visits/Audits (SQVs) from the study sponsors
• Liaising with various support departments such as Aseptic Production Units on managing studies
• Overseeing progress of new study set up works by the Technical team and finally issuing greenlight for these studies

To maintain broader part of pharmacy service

• To participate in the operations of the Dispensary by being part of an agreed Rota
• To participate in other areas of pharmacy practice in case a need for such situation arise in order to meet the demands of Clinical Trials Pharmacy