Clinical Study & Regulatory Coordinator – Growth & Impact

University Health Network; Toronto; On-site; CAD 70,000 - 88,000; Full time

Benefits offered by this job

HOOPP pension plan

Transit access

Flexible work environment

Opportunities for development

Corporate discounts

On-site gym

Job summary

University Health Network invites applications for the Clinical Study and Regulatory Specialist I. The role leads study and regulatory coordination from activation to close-out of clinical trials.

You will prepare submissions, manage documentation, and support TMF/ISF maintenance in a fast-paced research environment. With a Bachelor’s degree in a health or science field and 2+ years in clinical research, you will ensure regulatory compliance and high-quality data management while collaborating

Qualifications

• Bachelor's degree in a health or science-related discipline required.
• Clinical Research Graduate Certificate preferred or equivalent.
• SoCRA/ACRP certification an asset.
• Minimum two years clinical or professional experience.
• Experience with regulatory/ethics submissions required.
• Knowledge of ICH/GCP, Tri-Council Policy, Helsinki Declaration and FDA/Health Canada guidelines.
• Strong data collection, management and analysis experience.
• Excellent written and verbal communication skills and teamwork.

Responsibilities

• Prepare regulatory submissions to local REB and regulatory agencies for approvals and amendments.
• Coordinate site qualification visits, feasibility surveys, initiation visits and protocol reviews.
• Manage regulatory documents, ethics submissions, protocols and staff training.
• Maintain study trackers and tools; update Data Management Plan as needed.
• Create or amend source documentation templates per data management requirements.
• Review and verify clinical data for accurate case report forms; ensure patient eligibility.
• Oversee data collection, entry, verification and reporting; resolve data queries.
• Coordinate on-site/virtual monitoring visits and audits by sponsors and regulators.
• Ensure regulatory compliance and manage study financials for the unit.
• Train new team members and support TMF/ISF maintenance.

Skills

Regulatory submissions

Clinical research

Data management

Communication

Teamwork

Attention to detail

Education

Bachelor's degree in health or science

Clinical Research Graduate Certificate

SoCRA/ACRP certification (asset)

Tools

MS Word

PowerPoint

Excel

Job description

University Health Network invites applications for the Clinical Study and Regulatory Specialist I. The role leads study and regulatory coordination from activation to close-out of clinical trials.

You will prepare submissions, manage documentation, and support TMF/ISF maintenance in a fast-paced research environment. With a Bachelor’s degree in a health or science field and 2+ years in clinical research, you will ensure regulatory compliance and high-quality data management while collaborating