University of Alberta

Regulatory Specialist (BB-49813)

Found in: Talent CA

This competition is open to all applicants however internal candidates and applicants who were former employees of the University of Alberta in the past 18 months will be given priority consideration before external candidates.This position is a temporary replacement with an end date of one year from the date of hire and offers a comprehensive benefits package which can be viewed at: .The Regulatory Specialist will work with the Clinical Trials Project Leads and be involved on multiple projects within The Canadian VIGOUR Centre (CVC). This position will be responsible for all aspects of regulatory document distribution, collection, review, tracking, and ensuring translations have been completed. This position will also be responsible for data entry, updating spreadsheets and trial related tracking documents, distributing SUSARs (Suspected Unexpected Serious Adverse Reaction), helping to prepare monitors for upcoming visits and closing action items as they are completed in the database(s). The position requires accuracy and a strong attention to detail with a good understanding of Health Canada regulation and ICH/GCP (International Conference on Harmonization/Good Clinical Practice).Duties Distributes, collects, follows-up on, sends for translation, reviews for completion and accuracy, and tracks regulatory documents, ethics correspondence and informed consent forms for sites across Canada for multiple projects, ensuring they meet regulatory requirements and International Conference on Harmonization (ICH)/Good Clinical Practice (GCP)Prepares communications and distributes SUSARs as required on multiple protocolsEnters and updates demographic Information, tracks regulatory documents, enters conversation logs with sites, and assists In closing monitoring action items in the Clinical Trial Management System (CTMS) or a similar databaseSupports semi-annual internal reviews of select study regulatory files to ensure they are being maintained in compliance with the appropriate SOPs and trial requirementsAssists in the ongoing transition and development of electronically based regulatory document storage and filing in accordance with ICH/GCP and regulationsUploads and enters data and regulatory documents into electronic trial master files (eTMF) on an ongoing basis throughout the trial and in preparation for archiving of studiesUpdates SharePoint, spreadsheets and any other study trackers as requested and required for multiple protocolsCommunicates directly by phone and email with sites to follow up on missing, expiring, incomplete or incorrect regulatory documentsMaintains investigator site files and trial master files ensuring all documents are file- and audit-readyPrepares and distributes study materials to sitesInputs patient-specific data for local projects as requiredReports daily/weekly on study progress/data/issues and/or as required to Clinical Trials Project Lead responsible for the study and to SupervisorAssists with updating and preparing required documents/updates for the monitors in advance of monitoring visitsAssists with trial archival inventory and arranges for proper storage of records according to standard operating proceduresAssists with pulling reports and follows up with sites on outstanding or incomplete dataActs as a resource for sites with regards to regulatory document completionCollaborates closely with Clinical Trials Project Leads and supervisor regarding prioritizing work on each of the studies Qualifications Post-secondary degree, preferably in sciences or health sciencesMinimum two years' relevant experience in a research environmentExperience with MS office suite and databases, SharePoint, Gmail, CTMS, Medidata RAVE and REDCap, data entry, etcGood understanding of Health Canada regulations and ICH/GCPAccuracy and strong attention to detailKnowledge of medical terminology an assetStrong Interpersonal skills for communication with study coordinators, collaborators and Internal teamExcellent verbal and written communication skills, and strong attention to detailBilingual (English and French) an asset

calendar_today4 days ago


info Full Time - Grant Funded

location_on Edmonton, Canada

work University of Alberta

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