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    Senior Research Coordinator - Toronto, Canada - Baycrest

    Baycrest
    Baycrest Toronto, Canada

    5 days ago

    Default job background
    Full time/Regular
    Description
    Responsibilities include but are not limited to:Responsibilities include but are not limited to:
  • Coordinates, monitors and supervises all study activities to ensure proper execution of assigned clinical research trials and to ensure that study protocols, SOPs, ICH-GCPs and regulatory requirements are met.
  • Acts as a Leader by advising CRCs, Study Preparation Associates, Clinical Research Technicians, and Safety Staff on proper trial execution based on protocol, SOP, and regulatory requirements.
  • Conducts CRC and RA training.
  • Meets and addresses issues with study monitors, sponsors and regulatory agencies as appropriate
  • Respond to queries by internal departments on trial conduct
  • Participates in review and development of study protocols, SOPs, and internal procedures
  • Analyzes and develops action plans to address QC/QA findings, including development of CAPA reports
  • Participates in development, revision and implementation of clinical, general and other applicable SOPs, Directives and internal procedures as required, ensuring consistency with GCP, regulatory, and/or Sponsor requirements
  • Performs CRC, RA and/or Study Preparation Associate duties if required
  • Maintains adequate, accurate, complete and legible records
  • Detailed review of study participant and study documentation, CRFs and source documents
  • Conducts Protocol training for clinical research staff and Investigators.
  • Works with QC and QA during audits and audit follow-ups
  • Maintains current professional knowledge base of clinical research methodologies and regulatory requirements (FDA, TPD, etc.)
  • Performs other tasks as assigned and as training and experience allow
  • Serve as primary contact for multiple studies/sites
  • Prepare for and conduct study monitor visits and audits
  • Serves as a liaison to physicians, investigators, patients and other staff members regarding the research process and individual protocols
  • Submit and Review Institutional Review Board documents
  • Strategizes and helps troubleshoot to correct problems
  • Escalates issues as needed to supervisor


    • Qualifications include but are not limited to:

  • 3-5 years work experience as a Clinical Research Coordinator
  • Certification as a Clinical Research Professional (SOCRA, ACRP, etc.)
  • Current GCP and familiarity with Health Canada, FDA, ICH GCP regulations
  • Current GCP, Health Canada Part C Division 5, IATA certifications
  • Completed postsecondary degree in a science or healthcare related discipline, or equivalent work experience.
  • Ability to work in a fast paced environment with a high degree of organization.
  • Experience with Microsoft Office (Word, Excel, Power point, etc.)
  • Phlebotomy certification

    • Required Skills:

  • Excellent organization and attention to detail
  • Quick and eager learner
  • Ability to work independently
  • Strong critical thinking
  • Excellent oral and written communication
  • 3-5 years of experience in related field
  • Working knowledge of research methodology/medical terminology
  • Meticulous work ethic and attention to detail, with excellent time-management and organizational skills.
  • Ability to manage competing demands of short and long-term projects led by numerous individuals, directing multiple varied assignments, independently coordinating and prioritizing relevant projects, tasks and responsibilities.
  • Highly motivated and adaptable with an ability to take initiative and work well independently and as part of a multidisciplinary team.
  • Ability to produce high quality work while meeting deadlines in accordance to CTU standards.
  • Ability to maintain confidentiality.
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