Clin. Res. Project Coord.-RI - 12336
SickKids
Toronto, Ontario
2d ago

The Clinical Research Project Coordinator (CRPC), under the supervision of the study PI, will be responsible for the central coordination of a randomized controlled trial across multiple sites.

This includes study start up activities and study execution. The CRPC also assists in the preparation of study progress reports, presentations, results, and manuscripts.

Here’s What You’ll Get To Do

  • Centrally coordinate a multi-site randomized controlled trial in accordance with ICH / GCP
  • Prepare study protocol(s) and associated study documents and oversee submission to institutional ethics boards across multiple sites
  • Oversee study amendments, prepare document revisions
  • Assist P.I. with science review process
  • Develop study binders for clinical department and study team use
  • Organize materials to facilitate protocol adherence, including study binders and checklists of eligibility
  • Monitor and follow-up on adverse events including filing reports with internal and external regulatory bodies, notification of collaborators and / or patients
  • Foster collaborative relationships with the healthcare team at SickKids and other study sites
  • Assist with database design. Ensure the quality of the database and supervise database cleaning. Perform / assist with data entry and analysis including planning
  • Coordinate weekly conference calls with study research teams across multiple sites
  • Participate in audits, site visits and monitoring by SickKids and other regulatory bodies, as required
  • Attend relevant departmental meetings or rounds in order to increase knowledge and understanding
  • Assist with design / development of promotional materials / newsletters
  • Supervise Clinical Research Assistants across multiple study sites
  • Assist in training / orientation of new research staff
  • Maintain budget records
  • Perform patient interviews and assessments as required by study protocols
  • Support other team members, including trainees, on team projects, as required
  • Keep abreast of regulations and policies governing clinical research
  • Conduct literature reviews and keep current with study literature
  • Here’s What You’ll Need

  • Masters degree with 3-5 years related clinical research experience
  • Must have experience coordinating multi-site randomized controlled trials
  • Certification as a clinical research associate (e.g., SOCRA, ACRP accreditation) is an asset
  • Ability to function independently yet collaboratively within a team
  • Effective communication, interpersonal, facilitation and organizational skills
  • Experience with psychiatric research an asset
  • Experience in database design and maintenance preferred
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