Detailed job description and main responsibilities

GENERAL DUTIES

General

Contribute to policy development for NUH.

The post holder must ensure GCP and R&I SOP training is complete and their training records are up to date.

Maintain precise and accurate quality management records that are ready for inspection by regulatory bodies and Sponsors on demand.

 Undertake quality control checks of research activity undertaken within and on behalf of NUH, in conduction with our partners, including but not limited to our suppliers, BRC Partners, the CRF and Clinical Trials Unit.

Through monitoring, support the management of systems to document accountability and traceability of Investigational Medicinal Products (IMPs)/study drugs in order to make certain that their receipt, storage, dispensing, administration and disposal is undertaken in accordance with local SOPs.

Recognise and respond to research governance and quality issues that might arise during quality control checks.

Recognise and act upon departures from legislative and research governance requirements including failure to follow protocols and/or SOPs, responding appropriately and escalating as required, for example, reporting serious breaches in accordance with the Medicines for Human Use (Clinical Trials) Regulations.

Promote a quality culture among NUH and our partners researchers.

Liaise with members of medical and non-medical staff regarding research quality management issues where appropriate. Maintain good working relationships with academic and service departments in order to promote effective teamwork.

Recording and reporting incidents to the R&I board and the wider research teams when appropriate, ensuring that staff involved with incidents provide all necessary reports, submissions and notifications to the attention of R&I and regulatory authorities.

Work autonomously and efficiently.

Maintain effective communication across NUH where non-compliances have been identified through monitoring, or inspection.

Ensure that any Trust reporting systems, including DATIX, are utilised appropriately.

Meet with the Research and Innovation Head of Research Governance, Quality and Integrity (HRGQI) on a regular basis to provide feedback on workload and quality management activities.

Organise and chair regular quality management operational meetings e.g. Monitoring visits, Training performance.

Work in accordance with Trustwide policies and procedures.

Assist in any information governance or potential fraud and misconduct issues identified through quality control activities or inspection.

Maintain knowledge of legislation and guidance governing clinical research and quality management processes, for example, through attending conferences, training courses, or through relevant networks or forums. 

Education and Training

Maintain a high level of knowledge relating to the EU and UK legislation, regulations, management and conduct of research and act as an NUH expert on these matters.

Maintain personal training record. 

Documentation Management

Overall Management of the R&I GCP documentation e.g. policies, SOPs and forms.

Manage the preparation, review and approval of policies, standard operating procedures and forms, ensuring that all regulatory and Trust requirements are encapsulated.

 Manage the documentation control of SOPs and forms.

Manage the biennial review process for SOPs.

Ensure SOPs and forms are published in the correct format and location. 

CAPA Management

Identify and report incidents requiring corrective and preventative actions to the Quality Assurance Manager. 

Training Management

Collaborate with the R&I Workforce Development Team to ensure an appropriate training matrix for all R&I staff.

Overall management and tracking of the R&I workforce compliance with the training matrix.

Oversight of training on policies, SOPs, templates and other appropriate documentation for R&I staff and researchers, ensuring this is appropriately documented.

Provide metrics on training completeness to the HRGQI for quarterly reporting.

Manage the process for retention of staff training records in accordance with Trust Policy.

Provide support and advice to NUH researchers regarding the principles of ICH-GCP and compliance.

Assist the HRGQI, QA Manager, Research Governance Manager and Workforce Development Team in preparing and delivering targeted training programmes of the principles of ICH-GCP, research governance, compliance and quality management to departments involved in research and pharmacovigilance activities, and other members of the Research and Innovation department.

 Vendor Management

 Overall Management of the R&I Approved Vendor system.

Risk assess vendors following review of associated due diligence documentation, including the vendor questionnaire, and activities.

Approve or reject vendors on completion of due diligence documentation and activities.

Review vendors in accordance with associated standard operating procedures.

 Inspections

In collaboration with the HRGQI and senior management team, conduct the appropriate preparation for local inspections. 

Provide support during the conduct of local inspections. 

Assist in providing responses to inspection findings and coordinating corrective and preventative actions.

 Monitoring

 Develop, maintain and deliver a risk-based monitoring programme for the research and pharmacovigilance functions within NUH to determine on-going compliance to the research protocols, principles of ICH-GCP, regulatory requirements, and NUH SOPs and policies.

Review risk assessments and monitoring plans to ensure a risk proportionate approach to monitoring.

Review and define acceptable error rates, and take appropriate actions to address any failure to meet required standards.

 Interact with research teams and departments to arrange monitoring activities, to include (but not limited to):

Source data verification

Consent processes

Pharmacovigilance activities

Accountability (investigational medicinal products, devices and equipment, and clinical samples)

Ensure the monitoring programme is annually reviewed and is risk based.

Liaise with research teams to ensure monitoring reports are complete, overseeing completion of any actions.

 Ensure all monitoring findings are relayed to the appropriate teams, such as the Quality Assurance Manager and HRGQI so that any corrective and preventive actions can be put in place where necessary, which may include triggering audits for the QA team.

Ensure that these monitoring activities are documented and that findings are disseminated within NUH in order to drive continuous improvement to procedures.

 Ensure all overdue monitoring visits are escalated to research team, HRGQI and senior R&I management (where required).

Assist in the preparation of complex reports for the relevant QC oversight committees, documenting monitoring activities, metrics, findings and resolutions.

 This list of responsibilities is not exhaustive, the post holder will be expected to undertake any other relevant duties appropriate to the grading of the post.