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Research Coordinator - Regulatory - Jobs in Brampton

William Osler Health System
Job LocationBrampton
EducationNot Mentioned
SalaryNot Mentioned
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent

Job Description

Job DescriptionWe are looking for a highly competent, organized, meticulous and personable candidate to join our growing team. As an integral part of the Research team, you will perform all tasks associated with the regulatory management of research protocols within the Department of Oncology at Osler. You will contribute to the maintenance of the quality system, ensuring compliance to industry standards and regulatory requirements and ensuring the research team is audit ready at all times.The Regulatory Research Coordinator reports to the Manager of Research, Oncology, with accountability to the Oncology leadership team.Accountabilities:

  • Manages all aspects of regulatory oversight for trials, from start-up through study closeout, and protocols in development
  • Works closely and collaborates with research manager and principal investigator to develop and complete necessary documentation prior to start-up activities
  • Prepares Research Ethics Board (REB) applications and submissions, amendments and annual renewals
  • Develops, reviews and edits informed consent documents, ensuring compliance with local and sponsor regulations
  • Reports pertinent safety data and deviation notifications to the REB
  • Prepares, reviews, and submits – under principal investigator delegation –safety reports quarterly or annually
  • Adheres to all appropriate regulations in the conduct of research
  • Develops function scorecard and track progress of start up activities
  • Maintains study trial delegation of responsibility logs and keeps record of all training documentation for site staff; tracks training requirements and ensures all training is completed
  • Facilitates internal and external monitoring and auditing of regulatory files by the sponsor, contract research organization, or other entity; ensure regulatory binders are organized, complete and up to date prior to monitoring visit or audit
  • Reviews and adapts existing standard operating procedures, templates, databases and organizational systems as developed for the management of regulatory and quality assurance activities
  • Maintains regulatory binders, ensuring all relevant sections of binder are organized, complete and up to date
  • Ensures accurate and timely data collection, transcription, and entry; timely reporting of adverse events and serious adverse events to study sponsor, physician and appropriate authorities; resolves sponsor queries
  • Participates in educational programs, workshops and seminars to broaden knowledge, update and develop new skills
  • Represents the Oncology Department at protocol development, study initiation and investigator meetings

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