21 Aug
|
St. Joseph's Health Care London
|
London
21 Aug
St. Joseph's Health Care London
London
Lawson
Parkwood Institute Main - London, ON
Temporary Full Time
Salary Range: $34.40 - $43.00 /hour
This is a temporary full-time position that is anticipated to extend until September 20, 2027, and is subject to the availability of work.
The successful candidate will support the Clinical Trials Transformation Initiative in implementing strategic projects that strengthen, modernize, and streamline clinical trial operations under the direction for the Research Operations Manager.
The role of Clinical Trials Transformation Coordinator includes coordinating transformation projects; supporting standardized clinical trial start-up, feasibility, regulatory, contracting, budgeting, recruitment, and performance-monitoring processes; developing tools, procedures, training resources, and reports; and facilitating implementation of new technologies and service models.
Essential Qualifications
- Bachelor’s degree in health sciences, life sciences, business, public administration, project management, or related discipline, or equivalent education and experience required
- 2 years of related experience in clinical research, clinical trial operations, research administration, project coordination, quality improvement, or health-system transformation required
- Experience supporting clinical trial feasibility, study start-up, research ethics, regulatory, contracting, budgeting, recruitment, or trial-management activities
- Experience working with clinical trial management systems, electronic research platforms, data-capture systems, or comparable digital tools
- Demonstrated professional writing skills, including procedures, briefing notes, project documentation, reports, presentations, and training materials
- Knowledge of clinical research operations, institutional policies, standard operating procedures, and research-governance practices
- ICH-GCP Certification: Current certification in Positive Clinical Practice standards,
including a strong understanding of the updated ICH E6(R3) framework.
- TCPS 2 Core: Completed Tri-Council Policy Statement (TCPS 2: 2022) training.
- Regulatory Knowledge: Solid understanding of Health Canada Food and Drug Regulations (Part C, Division 5).
- Privacy Compliance: Knowledge of Personal Health Information Protection Act (PHIPA) for handling patient data.
- Ability to work independently with minimal supervision and collaboratively within multidisciplinary, cross-functional teams
- Strong project-management and organizational skills with the ability to manage competing priorities, coordinate multiple workstreams, and meet deadlines
- Demonstrated excellent communication, facilitation, consultation, and relationship-management skills, both verbal and written
Key Responsibilities
- REB Management: Coordinate, write, and submit applications, amendments, and renewals to local Research Ethics Boards or via Clinical Trials Ontario (CTO).
- Institutional Approvals: Coordinate internal hospital department signoffs (e.g., Pharmacy, Imaging, Labs) to ensure operational feasibility before study launch.
- Regulatory Compliance: Maintain the Investigator Site File (ISF) and ensure trial documentation adheres to Health Canada's 15-year record retention mandate.
- Health Canada Liaison: Assist in preparing documentation for Clinical Trial Applications (CTA), amendments, and inspections.
- Data Integrity: Manage patient records and source documentation while strictly upholding PHIPA privacy guidelines.
Preferred Qualifications
- Master’s degree in health sciences, life sciences, business, public administration, project management, or related discipline
- Change management, process improvement, implementation science, quality improvement, or program evaluation experience
Immunization Requirements
- Provide vaccination records or proof of immunity against measles, mumps rubella, varicella (chicken pox), Hepatitis B, COVID-19 and influenza.
- Provide documentation of the Tuberculosis skin testing
📌 Research Coordinator 1, Lawson (London)
🏢 St. Joseph's Health Care London
📍 London