Senior Clinical Trials Facilitator - Study Set up Specialist

Job overview

This is an exciting opportunity to join our Clinical Trials Division – Pharmacy. The department manages, between two sites (Guy’s Hospital and St Thomas’ Hospital), a portfolio of over 1000 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.

The post holder will be predominantly acting as a Clinical Trials Set Up specialist for new studies in line with GCP principles.

Main duties of the job

Clinical Trials Pharmacy Feasibility

Clinical Trials Pharmacy Set-Up

Clinical Trials Study Management

Research Quality and Governance

Maintain key relationships with the following:

• Internal:
• All Trust staff undertaking research (clinical and non-clinical)
• Trust R&D Leads
• 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

Detailed job description and main responsibilities

Site Qualification (SQ)

To undertake following activities and/ or responsibilities linked to site selection:

• On site pharmacy qualifications, capacity and capability: To engage with Trial Sponsors, Clinical Research Organisations (CROs), Principal Investigators, site level clinical research staff, Pharmacy support departments (e.g. Aseptic Units, Pharmacy Manufacturing Units, GMP), local pharmacy staff and external contractors who provide services on IMP management
• Provide pharmacy capacity and capability assurance to Sponsors, R&D and King’ s Health Partners Clinical Trials Office (KHP CTO)
• Work alongside Pharmacy Clinical Trials Mangers on ensuring key research resources and capabilities are sourced and maintained in line GCP and GMP
• Demonstrate solution focused approach to site qualification and communicate with key research partners accordingly.
• Create and maintain key documents such as standard operating procedures that are essential for assuring site qualifications

Site Selection and Feasibility

• Engage with KHP-CTO and R&D on study site selection compliance relevant to commercial and non-commercial studies
• Engage with KHP-CTO and R&D study facilitators in order to source and organise key study documents required to run Clinical Trials Pharmacy
• Engage with KHP-CTO and R&D costing and contract team on finalising study costing and Clinical Trials Agreements (CTA)
• Undertake National Costing Value Review (NCVR) on behalf of Pharmacy
• To work with Investigators to scope the feasibility of studies and assess the support requirements of each project
• Support Clinical Trials Pharmacists in the process of conducting study feasibility review and issuing of Full Approval: a.     Review, analyse and interpret key study documents such as Clinical Study Protocol and Investigator Brochure b.     Extract and condense relevant information from key study documents and translate it in to Trials Specific Pharmacy Procedures and other key pharmacy documents c.     Engage with support departments in ensuring their capacity, capability and cooperation d.     Ensure all study regulatory approvals are in place before a Full approval is issued e.     Complete all administration tasks linked to study feasibility
• Issue Full approval for the study and costing

Trials Set up

To undertake following activities and/ or responsibilities linked to Trials Set Up

• Create Pharmacy Site Folders (PSF) in line with departmental procedures and ensure compliance to GCP
• Engage with EPIC (Electronic Patient Records) and facilitate building site level electronic prescription platform: submit key documents relevant for EPIC drug file building. Training and support will be provided for EPIC and other sponsor-specific systems in line with departmental procedures
• Draft Trial Specific Pharmacy procedures relevant to each study
• Seek pending regulatory approvals
• Draft site level Investigational Medicinal Products (IMP) finished dose preparation documents
• Undertake IMP specific relevant training specific to research nurses and key study personnel
• Ensure appropriate study specific delegation of duties to key study pharmacy personnel
• Ensure all relevant Policies and Standard Operating Procedures of the GST-Trust, R&D and Pharmacy are followed during the study set up
• Engage with Sponsor and site level clinical research personnel on set up progress and solving set up challenges
• Undertake sponsor level key trainings on protocol, IMP management  and Interactive Response Technology (IRT)
• Attend Site Selection Visit (SIV) and complete Delegation of Duties for Pharmacy Personnel
• Complete the Trial set up and facilitate study pharmacy greenlight.
• Collaborate with Pharmacy Technical Services to support and facilitate trials requiring extensive technical involvement.

Study Management

To undertake following activities and / or responsibilities linked to study management at site:

• Once the study is open, work alongside CT Pharmacy personnel on study management: a.     Act as an interface between site level clinical research team, sponsor, CRO and other support departments b.     Support study amendment team on review of amendment documents, Confirmation of Capacity and Capability (CC&C) and implementation c.     Work alongside CT Pharmacists on ensuring Good Clinical Practice and Quality assurance d.     Support R&D Quality assurance on Audits, CAPA and filling
• Engage with various clinical directorates in order to run the study efficiently and smoothly.
• Support Clinical Trials Team in managing IMP at site level, which includes shipments, IRT/IWRS, onward communication with the sponsor, reporting any deviations, IMP issuing to the clinical team and any sub-delegated activities linked to a particular study
• The postholder may provide task-based leadership and contribute to training, but the role does not carry formal line management responsibilities

Research Quality and Governance

To undertake following activities and / or responsibilities linked to study management at site:

• To provide Governance support to the R&D Manager and Research Governance Specialists in relation to their R&D responsibilities
• To act as the pharmacy specialist, contact within the R&D Office for seeking relevant approvals and documents, and as a source of advice and information for R&D including the dissemination of Pharmacy information
• To act as a point of co-ordination, liaison and advice for site clinical research team, investigators and Pharmacy
• Maintain an in-depth understanding of new developments in NHS R&D management and governance
• Provide advice and guidance to NHS and GSTT investigators and other research-active staff regarding IMP management
• Answer IMP related queries from researchers and R&D on completing applications for research projects, submissions, sponsorship, and host site approval applications
• Maintain awareness of the pharmacy roles and responsibilities as a Sponsor Pharmacy, according to current regulations and guidance, and to communicate this to investigators
• Liaise with the Principal Investigator, Trust and KCL support departments and sponsors on internal requirements as necessary to ensure full approval is gained.
• Travel between sites and other organisations in order to liaise with researchers, R&D departments
• Keep up to date with:
• GCP
• MHRA guidance
• NIHR and HRA publications
• NCVR and contract developments
• Comply with all other relevant institutional policies
• Undertake such duties as may be required from time to time as are consistent with the responsibilities of the grade and the needs of the service