Clinical Research Coordinator

2 months ago

Toronto, Ontario, Canada University Health Network Full time

Job Summary

The University Health Network is seeking a highly motivated and organized Clinical Research Coordinator to join our research team at the Movement Disorders Clinic. As a key member of our team, you will be responsible for the administration and coordination of several clinical trials.

Key Responsibilities

  • Recruit and screen study participants, obtain informed consent, and coordinate complex patient visit schedules as per study protocol.
  • Plan, implement, and coordinate all aspects of study visits, including scheduling patient visits, arranging and uploading imaging scans, assisting with lumbar punctures and skin biopsies, documenting adverse events and concomitant medications, administering neuropsychological and cognitive questionnaires, eye tracking, sample collection, sample processing, and shipping according to study protocol.
  • Implement and coordinate all aspects of data collection and source documentation as per UHN policy and ICH/GCP guidelines.
  • Execute study-related administrative tasks, such as collating regulatory documents, submissions to the Research Ethics Board and other regulatory agencies as required, completing relevant study CRFs, logs, and entering data into databases in a timely manner.
  • Liaise with Contract Research Organizations (CROs), sponsors, external stakeholders, and members of the clinical research team.
  • Prepare and liaise with CROs/sponsors for monitoring visits and/or audits, organize and attend ongoing meetings.
  • Contribute to protocol development.

Requirements

  • Bachelor's degree in a health or science-related field or equivalent.
  • Minimum 1-2 years of clinical research experience and experience with patient contact.
  • Prior experience in the coordination and administration of clinical trials.
  • Experience with research regulatory submissions is a strong asset.
  • Phlebotomy certification preferred.
  • TDG (Transportation of Dangerous Goods) certification preferred.
  • Knowledge of IATA (International Air Transport Association) shipping regulations and laboratory procedures preferred.
  • Previous experience with neurological clinical trials and/or PI-initiated trials preferred.
  • Knowledge of research regulations and guidelines, such as ICH/GCP guidelines, Tri-Council Policy, Declaration of Helsinki, and FDA CFR and Health Canada TPD.
  • Ability to perform duties in a professional and courteous manner and produce high-quality work while meeting deadlines in accordance with UHN standards.
  • Exceptional organizational and time management skills and attention to detail.
  • Ability to multitask and perform with accuracy in a fast-paced environment.
  • Well-developed leadership and excellent interpersonal skills.
  • Self-motivated; ability to work well independently as well as part of a team.
  • Strong analytical and problem-solving skills.
  • Strong verbal and written communication skills.
  • Excellent decision-making, listening, and conflict resolution skills.

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