Regulatory Affairs Officer

Location
Dublin (Hybrid model)
Contract Type
Permanent Full-time
Closing Date
30th December 2021

Reports to:
Head of Quality & Training

Key Requirements

  • Science and/or medical/ or nursing background
  • Minimum of two years’ clinical research experience, including involvement in ethics and regulatory submissions
  • Knowledge of EU regulatory and ethics submission processes for clinical trials; knowledge of international submission processes for clinical trials preferred
  • Versatility and ability to work to tight deadlines and understanding of requirement to work to regulatory timeframes
  • Team player and possess the ability to work independently
  • Excellent written and verbal communication, interpersonal, analytical and negotiation skills

Main Function(s)

  • Ensure that ethics and regulatory submissions for Cancer Trials Ireland-sponsored and externally-sponsored trials managed by Cancer Trials Ireland are in compliance with the applicable ethics and regulatory requirements and Cancer Trials Ireland/external sponsor SOPs, where applicable.
  • Provide expertise on the applicable ethics and regulatory environment, legislation and guidelines to Cancer Trials Ireland Study Team(s).
  • Track and process and documents associated with the ethics and regulatory submissions and communications

Primary Responsibilities

  • Act as the point of contact (applicant) for ethics committees and regulatory authorities for all submissions and correspondence for both Cancer Trials Ireland-sponsored and externally-sponsored trials.
  • Liaise with external sponsors to prepare, review and submit ethics and regulatory submissions for externally-sponsored trials managed by Cancer Trials Ireland (initial application, query responses, approval, amendments, annual updates through to close of study).
  • Prepare and/or review documentation supporting submissions for externally sponsored trials, primarily patient information leaflet/informed consent forms and patient-related documents incorporating all relevant local adaptations.
  • Develop and maintain strong working relationships with internal and external stakeholders/Sponsors.
  • Prepare ethics and regulatory submissions in Ireland and internationally as required, for Cancer Trials Ireland-sponsored clinical trials in accordance with defined timelines and in compliance with relevant SOPs, and ethics and regulatory requirements.
  • Prepare, review and submit substantial and non-substantial amendments, Annual Progress Reports, End of Trial declarations and other applicable documentation to ethics committees and regulatory authorities in collaboration with Cancer Trials Ireland Study Team(s).
  • Ensure the accuracy of ethics and regulatory documentation.
  • With the QTM and/or Senior ERC, keep Cancer Trials Ireland staff informed and updated in current and updated ethics and regulatory submission and approval processes, and requirements, as required.
  • Inform Cancer Trials Ireland Study Team(s) and external sponsors of ethics committee and regulatory authority decisions and outcomes of submissions, liaise with Cancer Trials Ireland Study Teams, collaborators on Cancer Trials Ireland-sponsored trials and external sponsors on the collation of responses to queries from ethics committee and regulatory authorities and/or requests for further information, according to specified timelines.
  • Maintain internal Cancer Trials Ireland trackers for ethics and regulatory submissions and approvals.
  • File all documents related to ethics committee and regulatory authority including submissions, approval, correspondence, acknowledgments and other relevant documentation in the Trial Master File and electronically in the relevant trial folder.
  • Update Cancer Trials Ireland Operations and Project Management teams on the ethics and regulatory status of trials regularly and on request.
  • Input in SOP (Standard Operating Procedure (SOP) development and updates related to ethics and regulatory processes as well as patient-related documents as required.
  • Attend relevant training courses in relation to the requirements to fulfil this role successfully and as specified by the Line Manager.
  • Organise, attend and participate in meetings as required.
  • Prepare and present/ provide training on ethics and regulatory processes as required.
  • Provide support to Cancer Trials Ireland and external sponsors during the preparation, conduct and follow-up of sponsor audits and regulatory inspections.
  • Perform other tasks as specified by the Line Manager.