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Detailed job description and main responsibilities

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

 ·     Support the management and monitoring 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 assurance 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.

 ·     Promote a quality culture among NUH and our partners researchers.

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

 ·     Recording and reporting adverse events/adverse reactions 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 on the quality assurance audit programme.

 ·     Maintain effective communication on quality assurance systems across NUH where non compliances have been identified through audit or inspection.

 ·     Ensure that any Trust reporting system, including Datix, are utilised appropriately when required and if reported safety learning reports relate to protocol deviations, appropriate follow-up action is taken.

 ·     Meet with the Research and Innovation Head of research Governance, Quality and Integrity (GRGQI) on a regular basis to provide feedback on workload and audit progress.

 ·     Organise and chair regular QA operational meetings e.g. Audit & CAPAs, Training performance.

 ·     Work in accordance with Trustwide policies and procedures.

 ·     Liaise with NUH departments to ensure the facilitation of the transition to electronic patient records.

 ·     Assist in any information governance or potential fraud and misconduct issues identified through audit or inspection.

 ·     Attend QA/GCP HRA/MHRA conferences and training 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.

 ·     Provide support and advice to NUH researchers regarding ICH-GCP and compliance.

 ·     Assist the HRGQI in preparing and delivering targeted training programmes 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.

  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

 ·     Overall Management of the R&I CAPA system i.e. tracker and documentation.

 ·     Meet with CAPA owners on regular basis to ensure timelines are feasible.

 ·     Provide metrics on CAPAs to the HRGQI for quarterly reporting.

  Training Management

 ·     Overall Management of the R&I Training system including the R&I Induction and annual GCP Safety Training programme.

 ·     Issue SOP training to R&I staff and researchers, follow up on training completeness.

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

  Vendor Management

 ·     Overall Management of the R&I Approved Vendor system.

 ·     Issue vendor questionnaires and follow up on completeness.

 ·     Provide metrics on Training completeness to the HRGQI for quarterly reporting.

  Audits and Inspections

 ·     Provide input into the development of the audit strategy and quality assurance function.

 ·     Maintain and deliver the audit programme for the research and pharmacovigilance functions within NUH to determine on-going compliance to ICH-GCP, regulatory requirements, research protocols and NUH SOPs and policies.

 ·     Interact with research teams, departments and vendors in order to perform:

 -       Investigator site audits,

-       Vendor audits,

-       Pharmacovigilance audits,

-       Process audits,

-       Documentation audits.

 ·     Ensure the audit programme is annually reviewed with the HRC and is risk based. Work with the HRC to determine vendor audit requirements and ensure vendor audits are scheduled as part of the annual audit programme (where required).

 ·     Maintain robust systems to protect the rights of research participants, acting to prevent the disclosure of sponsors’ proprietary information or subjects ‘identity except to authorised individuals e.g. external audits

 ·     Liaise with research teams to ensure audit responses and findings are complete.

 ·     Ensure all audit findings are relayed to the HRGQI so that any corrective and preventive actions can be put in place where necessary.

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

 ·     Ensure all overdue audits are escalated to research team, HRCQI and senior R&I management (where required).

 ·     Support preparation for and facilitating external audits carried out by Sponsors and regulatory bodies.

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

 ·     Assist in the preparation of complex reports for the Clinical Effectiveness Committee documenting audit activities, metrics, findings and resolutions.