Analyze, question, and improve how clinical trial work is done while meeting business objectives through productive, quality trial execution from startup to closeout
Execute core clinical operations activities, including site management, SIV, IMV, closeout visits, and Trial Master File (TMF) maintenance
Participate in reviews of site contracts, budgets, and ethics board submissions
Build and maintain effective relationships with study personnel
Investigate issues independently, identify root causes, and propose solutions
Ensure study data are accurate, complete, and verifiable through SDR/SDV and on-site, remote, or centralized monitoring
Analyze site and study data to identify inconsistencies, trends, and potential risks, and develop mitigation strategies
Engage sites to improve protocol understanding and execution
Communicate findings, issues, and recommendations clearly and concisely
Maintain clear, logical, compliant, and inspection-ready TMF documentation
Improve processes, clarity, and efficiency
Ensure study conduct, TMF, and adverse event reporting comply with ethics board approval, GCP guidelines, and applicable regulatory requirements
Conduct training for colleagues or the study team as requested
Perform other duties as required by the company
Requirements Bachelor’s degree in biomedical sciences required
MSc (thesis-based preferred) or equivalent research experience
SOCRA/CCRP or ACRP certification preferable, or completion of a clinical research graduate certificate
Minimum of 1–3 years of experience
Strong written communication skills
Ability to think critically beyond following process
High initiative, ownership, and work ethic
Ability to structure and present information clearly
Experience administering and conducting clinical trials from startup to closeout
Proficiency in GCP guidelines, ethics board policies,



applicable regulatory requirements, and related processes
Proven ability to establish and maintain relationships with study site personnel
Proficiency in data management and quality management
Knowledge of adverse event reporting procedures and applicable regulatory requirements
Experience conducting site initiation, monitoring, and close-out visits, both onsite and remotely
Ability to manage multiple tasks, track project milestones, and ensure timely delivery
Ability to work independently and collaboratively
Ability to travel up to 60% of the time for site visits, monitoring visits, SIVs, and investigator interactions within Canada and the United States
Core Competencies Demonstrates expertise in clinical trial execution, including site management, TMF maintenance, and compliance with GCP guidelines and regulatory requirements. Proven ability to analyze data, improve processes, and communicate effectively with study personnel.
Highest-signal resume keywords Clinical Trial Execution
GCP Guidelines Proficiency
Site Management Experience
Data Management Skills
SOCRA/CCRP Certification
ATS Optimization Keywords Hard Skills Clinical Trial Management
Data Management
Quality Management
Adverse Event Reporting
Site Initiation
Monitoring Visits
Close-Out Visits
Trial Master File Maintenance
Regulatory Compliance
Budget Review
Soft Skills Strong Written Communication
Critical Thinking
High Initiative
Relationship Building
Collaborative Work
Certifications & Qualifications SOCRA Certification
CCRP Certification
Clinical Research Graduate Certificate
Industry Keywords Clinical Operations
Ethics Board Policies
Regulatory Requirements
SDR/SDV
Inspection-Ready Documentation
Process Improvement
Study Data Accuracy
Protocol Understanding
Risk Mitigation Strategies
Independent Investigation

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📌 Clinical Research Associate (Ontario)
🏢 Jobtailor
📍 Ontario