- Analyze, question, and improve how clinical trial work is done while meeting business objectives through efficient, 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
- Cooperative 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 (Mississauga)
🏢 Jobtailor
📍 Mississauga