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NCTO Quality Regulatory Affairs Manager, HRB-national Clinical Trial Office, College Of Medicine & Health

University CollegeCorkPart-time

Specific Purpose Part Time Post (0.4FTE)

(Anticipated duration 3 years)

UCC wishes to appoint an experienced professional to the role of NCTO-Quality and Regulatory Affairs Manager (QRAM) (Senior Research Co-Ordinator). The position is for a high-calibre experienced candidate to lead on the delivery of the HRB NCTO Quality Programme as per HRB NCTO’s programme of work 2021-2024, in collaboration with the HRB NCTO Manager, the HRB NCTO PI and the HRB NCTO team, working closely with CRF/C staff at a local level.

The HRB NCTO QRAM position will be funded for 3 years (0.4FTE) by the HRB funding award for the implementation of the National Clinical Trial Coordination Programme 2021. The successful candidate will work as part of the HRB NCTO team and will travel to the CRF/C’s, sites and other locations when necessary to carry out duties. The HRB NCTO QRAM will report to the HRB NCTO Manager and to the PI of the HRB NCTO award. The employment and HR policies UCC will apply to the employment of the successful candidate.

The HRB NCTO Quality and Regulatory Affairs Manager (QRAM) will:

  • Take the lead on the continued development of Standard Operating Procedures (SOP’s) for the HRB NCTO for its own central activities and for its service delivery to ensure that activities carried out within the HRB NCTO are conducted in accordance with ICH GCP guidelines, local legislation and the Clinical Trials Directives/Regulations where appropriate
  • Manage and co-chair the HRB NCTO Quality Working Group, coordinating regular meetings, developing annual work plans and delivering the planned activities and deliverables of the group
  • Manage and co-chair the HRB NCTO Pharmacovigilance Working Group, coordinating regular meetings, developing annual work plans and delivering the planned activities and deliverables of the group
  • Advise on the interpretation of complex legislation relating to clinical research, identifying the implications for HRB NCTO operations and acting to initiate necessary changes to practice in order to ensure that the HRB NCTO remains compliant with statutory regulations
  • Horizon scan and plan for change in regulatory requirements in the Clinical Research environment in Ireland.
  • Provide professional advice and signposting support relating to the regulation, management and conduct of clinical research in Ireland as appropriate to the role
  • Oversee all resource content for web portal and tools or documents developed for external use prior to upload and distribution
  • Be experienced in site auditing and monitoring
  • Provide guidance on mandatory research training (GCP, Medicines for Human Use (Clinical Trials) Regulations, Medical Device Regulations etc.)
  • Work with the HRB NCTO Manager in liaising with the HSE, university and hospital ethics and approval committees to work to improve hospital and ethical approval processes nationally
  • Coordinate the continued development and implementation of the long-term HRB NCTO Quality Management System in order to ensure that the HRB NCTO maintains a system of continuous quality improvement that meets the requirements of evolving clinical research legislation
  • Assist and input into the development of progress and grant reports for HRB NCTO
  • Participate as HRB NCTO ECRIN-ERIC observer when required
  • Perform any other duties that arise during the ambit of the post

Please note that Garda vetting and/or an international police clearance check may form part of the selection process.

For an information package including full details of the post, selection criteria and application process see https://ore.ucc.ie/ Job ID: 048251

The University, at its discretion, may undertake to make an additional appointment(s) from this competition following the conclusion of the process.

Informal enquiries regarding the post and the National Clinical Trials Office can be made in confidence to Dr Fionnuala Keane, Tel: 0861740103, Email: fkeane@ucc.ie

The closing date for applications is Thursday the 26th of August 2021

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