Senior Research Coordinator

3 weeks ago

Toronto, Ontario, Canada Baycrest Full time
Job Summary:

The Rotman Research Institute at Baycrest is seeking a Senior Research Coordinator to join our team. As a key member of our research team, you will be responsible for coordinating and supervising all study activities to ensure proper execution of assigned clinical research trials.

Responsibilities:
  • Coordinate and monitor study activities to ensure compliance with study protocols, SOPs, and regulatory requirements.
  • Supervise and advise Clinical Research Coordinators, Study Preparation Associates, and Clinical Research Technicians on proper trial execution.
  • Conduct training sessions for CRCs and RAs.
  • Meet with study monitors, sponsors, and regulatory agencies to address issues and concerns.
  • Respond to queries from internal departments on trial conduct.
  • Participate in the review and development of study protocols, SOPs, and internal procedures.
  • Analyze and develop action plans to address QC/QA findings.
  • Develop and implement clinical, general, and other applicable SOPs, Directives, and internal procedures.
  • Perform CRC, RA, and/or Study Preparation Associate duties as required.
  • Maintain accurate and complete records.
  • Review study participant and study documentation, CRFs, and source documents.
  • Conduct protocol training for clinical research staff and Investigators.
  • Work with QC and QA during audits and audit follow-ups.
  • Maintain current knowledge of clinical research methodologies and regulatory requirements.
  • Perform other tasks as assigned and as training and experience allow.
Qualifications:
  • 3-5 years of 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, PowerPoint, 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 a 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.
  • 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 with CTU standards.
  • Ability to maintain confidentiality.

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