Detailed job description and main responsibilities

Key job responsibilities

Clinical Trials Service Delivery, Governance and Development

  To be responsible for the day to day operational management and organisation of the pharmacy clinical trials technical service across all NUH sites.

 To manage operational priorities within pharmacy clinical trials, using available resources effectively and efficiently

To ensure compliance with ICH-GCP guidelines, clinical trial regulations, the research governance frameworks and other relevant guidelines and policies

To support the identification, planning and development of new opportunities for clinical trial services and provide advice and support for on-going services

To have an understanding of and contribute to development and implementation of the Medicines for Human Use (Clinical Trials) Regulations 2004 with relation to documentation, storage, handling and good clinical practice.

To ensure all records (including environmental monitoring) and working practices are to the standards expected under Good Manufacturing Practice (GMP), ICH-GCP and the Research Governance Framework, through audit and other means

To lead on maintaining and developing Clinical Trials SOP’s to ensure that all medicines research within the Trust is conducted in accordance with the relevant legislation and guidelines.

To oversee the work of other clinical trial pharmacy technicians in the setting up of clinical trials for the relevant speciality area in conjunction with the Assigned Specialist Clinical Trials Pharmacist and to set-up and manage a dedicated portfolio of specialist clinical trials (e.g. ATIMP and/or complex study set ups)

To oversee clinical trial technicians and assistants in maintaining trial records and stock

To assist in the investigation and management of internal and external clinical trial complaints from Sponsors and ensure that service improvements are implemented where appropriate.

To support clinical governance for clinical trials and management of processing Datix incident forms, and participate in investigation of, including follow-up and producing reports where appropriate for pharmacy clinical trial incidents including completing root cause analysis. To provide regular feedback to pharmacy staff of all incidents and complaints, ensuring all staff are aware of changes in practice arising from lessons learned

  support the delivery of an efficient, quality pharmacy clinical trials service to research teams, patients and clinical trial sponsor

To work collaboratively with the Principal Pharmacist Research and Innovative treatments, Advanced Pharmacy Technician R&I and Specialist Clinical Trials Pharmacists, to meet the inspection requirements of trial facilitators and study auditors, as well as MHRA GCP inspectors. 

To participate in the R&I department GCP Audit/Monitoring Programme for clinical trials managed by clinical trials pharmacy

Completing KPI data to facilitate monthly pharmacy clinical trials reports. 

Financial Resource Management

To ensure the claim mechanism for drug costs is completed and all invoices are generated in a timely manner

To oversee and coordinate the monitoring and pursuit of outstanding finance owed by trial sponsors, reporting back to the Advanced Pharmacy Technician R&I. 

 To document and monitor workload and trials income reporting and escalating to the Advanced Pharmacy Technician R&I.

Staff Management and training

 To lead, manage and act as a role model for the Pharmacy Technicians and Assistants, support staff

To be responsible for performance management and sickness absence management of direct line reports and support line managers with their team through the process.

In conjunction with the Advanced Pharmacy Technician R&I, to review vacancies as they arise and undertake the recruitment and selection of staff once the reviews have been completed.

To ensure that new staff receive comprehensive local induction and assessment in clinical trials dispensary and supply processes.

To assist the Advanced Pharmacy Technician R&I and the Specialist Clinical Trial Pharmacists in the development and maintenance of a structured package of training material for clinical trials. To be involved in training other healthcare professionals with respect to pharmaceutical issues as required.

To undertake development in project management such as completing the LEO course and leading on projects to develop the pharmacy clinical trials team.

To collaborate with R&I teams to support service development objectives. 

To delegate to senior pharmacy clinical trials technicians in the role out of service development projects and SOP review. 

Research and Development and Networking

 To undertake and participate in research delivery.

 To actively evaluate and integrate research evidence into practice to develop and improve pharmacy services within the directorate and the department. 

To support the forging of links, both nationally and regionally to share and promote best practice

To develop and maintain close working relationships with key stakeholders involved with clinical trials both within NUH (eg R&I staff and Research active clinicians) and with trial sponsors.