Clinical Research Study Coordinator

Humber River Health. Lighting New Ways In Healthcare.

Since opening our doors in 2015 as North America’s first fully digital hospital, we remain unwavering in our belief that we can change the hospital where we work, the community where we live, and the world of healthcare beyond our borders. Serving a community of 850,000 residents in North West Toronto, Equity Inclusivity and active participation in the North West Toronto Ontario Health Team are key initiatives important to our Team.  At Humber River Health, we use a custom combination of technology and clinical expertise to rebuild elements of care. We make technology work for staff and physicians; giving them more time to spend with patients, to eliminate inefficiencies, and to reduce the chance of errors. Humber River Health is formally affiliated with both the University of Toronto and Queen’s University and committed to becoming a community academic hospital. Clinical Excellence, Optimizing Care through Technology and Community Connection frame our Research Strategy.

At Humber River Health, we’re not hoping for a renaissance, we are making it happen. As part of our dynamic team, you can lead the way, as we continue our journey towards high reliability care!

The Clinical Research Office is seeking a highly motivated Clinical Research Study Coordinator to support and manage clinical research studies in compliance with regulatory guidelines, Good Clinical Practice (GCP), and study protocols. The ideal candidate will have strong organizational and communication skills, ensuring seamless coordination of study activities, patient care, and regulatory requirements.

Employment Status: Permanent Full Time

Hours of Work: Day shifts from Monday to Friday - subject to change as per Management Rights Location: Humber River Health, Wilson SiteEmployee Group: Non UnionReporting Relationship: Manager, Research

Responsibilities:

Study Coordination & Compliance:

• Coordinate and manage clinical research studies from initiation to close-out, ensuring adherence to protocols and regulations.
• Assist in the development and submission of study-related documents, including Research Ethics Board (REB) submissions and internal institutional approvals.
• Ensure compliance with Good Clinical Practice (GCP), Health Canada/FDA, ICH, and other applicable regulatory guidelines

Patient Recruitment & Retention:

• Screen, recruit, and enroll eligible study participants following inclusion/exclusion criteria.
• Obtain informed consent from study participants and ensure understanding of study procedures.
• Schedule and conduct study visits, ensuring adherence to protocol requirements.

Data Collection & Management:

• Collect and document study data accurately in case report forms (CRFs) and electronic data capture (EDC) systems.
• Maintain accurate and complete source documentation, ensuring data integrity and compliance.
• Report adverse events (AEs) and serious adverse events (SAEs) in accordance with protocol and regulatory requirements.

Regulatory & Documentation Management:

• Maintain essential regulatory documents, including site master files, informed consent forms, and protocol amendments.
• Assist with monitoring visits, audits, and inspections by regulatory agencies and sponsors.

Communication & Collaboration

• Serves as the primary point of contact between the study team, participants, and sponsors.
• Provides clear and accurate information to study participants and interdisciplinary teams, including physicians, nurses, pharmacists and laboratory staff, to facilitate study execution.
• Participate in investigator meetings, site initiation visits, and protocol training sessions.

Other duties as assigned

Requirements:

Education & Experience:

• Bachelor’s Degree in Health and/or Science related discipline required
• Certification in Clinical Research (e.g. Association of Clinical Research Professionals and/or Society of Clinical Research Associates) or equivalent certification required
• Minimum of 3 years of clinical research experience required

Skills & Competencies:

• Strong organizational and time-management skills with attention to detail
• Experience in MS Office (e.g., Outlook, Word, Excel, PowerPoint, Access, etc.)
• Knowledgeable in clinical research principles and practice, research regulations and guidelines (e.g. ICH/GCP guidelines, Tri-Council Policy, Declaration of Helsinki and FDA CFR and Health Canada TPD)
• Demonstrate knowledge in investigational product development process (e.g. drugs/biologics, devices, natural health products, etc.), IATA shipping regulations & laboratory procedures and investigator-driven research processes, such as mandatory reporting
• Knowledge of medical terminology required
• Interacts with both internal and external contacts primarily for the purposes of exchanging and/or clarifying of information, and resolving problems within scope of authority
• Ability to work independently and within a multidisciplinary team
• Demonstrates excellent competency in written and verbal communication

Why choose Humber River Health?

At Humber River Health, our staff, physicians, and volunteers are lighting new ways in healthcare. We are proud to be recognized as a part of Greater Toronto’s Top Employers by Mediacorp Canada Inc. We support employees by providing evidence-based leadership and cultivating a culture that consistently wows with our unwavering commitment to Staff, Physician and Volunteer engagement. We are a member of the Toronto Academic Health Science Network (TAHSN) and are deeply involved in research and academic collaboration. We are dedicated to high-quality patient care and demonstrate our values of compassion, professionalism, and respect.

Attracting and retaining a workforce that represents the diverse communities surrounding Humber River Health, is a priority.  We encourage applicants from all equity-deserving groups, including but not limited to, individuals who identity as Indigenous, racialized, seniors, persons living with disabilities, women, and those who identify as 2SLGBTQ.

Applicants will not be discriminated against on the basis of race, creed, sex, sexual orientation, gender identity or expression, age, religion, disability, medical condition, or any protected category prohibited by the Ontario Human Rights Code and Accessibility for Ontarians with Disabilities Act.

Accommodations are available throughout the recruitment process as well as during employment at Humber River Health. Please direct any accommodation requests to our recruitment team.