Full-time, Permanent
$35.08 - $43.86 an hour

The Applied Health Research Centre (AHRC) is an Academic Research Organization (ARO) at the Li Ka Shing Knowledge Institute of St. Michael’s Hospital in Toronto, with expertise in clinical study design, pragmatic methodology, and biostatistics. The AHRC has experience managing more than 200 multi-centre, national and international clinical trials, observational studies, and qualitative studies. It employs industry-leading web-based secure database technology, which incorporates advanced data validation and reporting tools. Over the past ten years, the AHRC has grown to be one of the largest AROs in Canada, and partners with diverse groups including the Toronto Academic Health Science Network (TAHSN), the Mayo Clinic, and the urban innovation hub MaRS.

The primary role of the Research Monitor is to plan and conduct both on-site and remote clinical research monitoring activities. On-site visits to research study sites will require at least 50% travel both nationally and internationally. This position reports into the Manager, Business Operations, however, day-to-day supervision is by the Lead, Research Quality.The Research Monitor works closely with our Research Compliance & Education Specialist and our team of Clinical Research Specialists.

DUTIES & RESPONSIBILITIES:

  • Plans and conducts both on-site and remote monitoring activities as defined in the protocol, GCP, SOPs and Sponsor requirements
  • Evaluates appropriateness of research sites to conduct the study, reviews and verifies site documents as required by protocol and GCP
  • Conducts source data verification (SDV) and other activities related to ensuring quality of trial data, adherence with applicable regulations and ensuring the rights and well-being of human subjects are protected
  • Reviews accuracy, completeness and timeliness of completed study records, case report forms (CRFs), and other documents
  • Documents monitoring activities in writing, using appropriate report formats, and promptly communicates deficiencies and/or issues to appropriate stakeholders and takes necessary actions
  • Works cooperatively with clinical research staff and investigators to address their concerns and to communicate findings that can lead to improved clinical research study performance and/or compliance
  • Participates in meetings and training activities
  • Conducts assessments of potential Serious Adverse Events and reporting to regulatory agencies
  • Works with sites to review barriers to recruitment, local site matters, and other related tasks
  • Prepares study monitoring plans, monitoring visit reports and related documents
  • Communicates with sites, internal study teams and study sponsors
  • Oversees other related research quality assurance duties as necessary

QUALIFICATIONS:

  • Minimum educational requirement of a bachelor’s degree
  • Certified Clinical Research Professional (CCRP) certification an asset
  • Requires ability to travel nationally and internationally (predominantly the USA)
  • Strong knowledge of ICH/GCP and Canadian/US regulatory requirements
  • 2 years + experience of on-site and remote monitoring of clinical research sites
  • Demonstrated initiative, willingness to learn
  • Excellent communication and writing skills
  • Strong team player while able to work independently/remotely
  • At ease with working under pressure and tight deadlines

Source:https://ca.indeed.com/jobs?q=Research&start=10&vjk=885cf5001f9e8797

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