City : Hamilton

Category : Other

Industry : Education

Employer : McMaster University

Clinical Research Coordinator IV (JD0573) 

Faculty of Health Sciences | Department of Oncology | Trials Research and Clinical Evidence (TRACE) Unit

McMaster University, Faculty of Health Sciences (FHS), is a leader in health research and innovation, providing a dynamic and collaborative environment for researchers and professionals. The largest Faculty within McMaster, FHS has an unwavering commitment to collaboration, strategic partnerships, accountability, innovation, excellence, integrity and optimism. Our pioneering approaches to education and our reputation for world-class research has consistently placed McMaster University among the Top 40 universities in the world for health and medicine. FHS enjoys close relationships with its academic hospital partners, as well as strong collaborations with researchers in Canada and around the world.

About TRACE

The Trials Research and Clinical Evidence (TRACE) Unit, https://www.tracetrials.ca, previously the Ontario Clinical Oncology Group (OCOG), is located within the Faculty of Health Sciences, Department of Oncology. TRACE was launched in January 2026 to expand beyond the work of oncology. TRACE is an academic-based clinical trials development and coordination organization. TRACE works with investigators to conceive, design, coordinate, conduct, analyze and publish early and late phase clinical trials. Together with a network of local, provincial, national and international clinician investigators, TRACE addresses clinically relevant questions with the ultimate goal to impact and improve patient care. Acting as an academic sponsor through McMaster University and HHS, TRACE conducts phase I, II, and III clinical trials.

Job Summary

We are seeking a dynamic individual who possesses the required knowledge and practical understating of regulations and guidelines governing the conduct of clinical trials involving human participants to lead and coordinate the regulatory components of clinical trials coordinated through TRACE, develop and implement ongoing training initiatives for research staff related to Health Canada regulations and ICH Good Clinical Practice Guidelines, particularly E6 (R3) and manage the daily operations of investigator led clinical trials. Reporting to the TRACE Scientific Director and Clinical Research Manager, the Clinical Research Coordinator is responsible for: 

Acting as the Primary Regulatory Resource to:

• Support TRACE leadership, PIs, and collaborators, in the development of clinical trial protocols and ICFs, especially those funded by industry to ensure safety requirements and adherence to regulations and guidelines for the conduct of clinical trials.
  • Ensure relevant research methodology is applied to clinical trial protocols and research materials for various types and phases of clinical trials.
  • Act as the primary liaison for Health Canada applications/submissions as well as the provincial applicant primary contact for applications to the Ontario Cancer Research Ethics Board.
  • Facilitate the TRACE Safety Desk, working with internal Medical Monitors and Research Coordinators to supervise and oversee the timely and accurate reporting of adverse events to regulatory agencies and industry collaborators.
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    Conduct internal audits and develop processes/plans to ensure Health Canada inspection readiness.

Managing Daily Operations of Multiple Clinical Research Projects:

• Develop implementation plans for research projects including the management of project timelines including estimates of start-up timelines and resources and ongoing tracking of milestones/deliverables throughout the clinical trial life cycle.
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  Plan and coordinate all aspects of clinical trials across multiple sites (both local and international).

• Develop and implement quality assurance procedures, inspection and internal auditing guidelines.
• Develop educational resources, ongoing review of existing policies and procedures.
• Coordinate and manage the collection, delivery, entry and verification of clinical data, while developing strategies to address the challenges at various clinical sites within Canada and internationally related to European regulations such as GDPR.
• Write operational documents.
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  Gather and compile information and data required for reports and disseminate data to research groups and collaborating partners.

  • Coordinate and lead meetings with internal staff, study PIs, industry collaborators, and external service providers.
  • Reporting: compiling summaries of clinical trial status, tracking and updating regulatory and ethics applications and associated clinical trial agreements.
   

   

Additional Skills:

• Above average organization skills with strong attention to detail.
• Superior project management skills with proven ability to prioritize tasks, meet deadlines and manage multiple projects simultaneously.
• Excellent interpersonal, oral and written communication skills (French language an asset). 
• Proven ability to work in a team environment and the ability to work with a wide range of internal and external stakeholders.
• Utilizing existing Electronic Data Capture (EDC) systems for the collection, verification of study data.
• Utilization of existing computerized systems (Clinical Trials Management System (CTMS) to organize and track regulatory and clinical trial study start-up activities.
• Must be a good facilitator providing guidance and support to internal and external clinical trial personnel.
• Proven ability to work in a team environment and the ability to work with a wide range of internal and external stakeholders.
• Computer literacy with advanced skills in Office 365, online meeting platforms and clinical trials management systems.

Requirements:

• Master’s Degree in a relevant field of study
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  Requires 6 years of relevant experience, including 1 year of supervision.

Additional Requirements:

• This role will be utilizing a hybrid working model (on-site 2 days/week (Wednesday/Thursday). Access to reliable home internet is required.