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- Employment type
- Contract
- Experience level
- Senior · 5+ years
- Minimum education
- Bachelor’s degree
- Posting language
- English
- Working hours
- 40 hours per week
- Location requirements
- Country, Ontario, Canada
- Seniority
- Mid-Senior level
- Application method
- Direct apply is available
Job summary
Conduct independent site monitoring, including source data verification and review of informed consent and regulatory documents. Manage site records, contracts, investigator files, and budget negotiations while maintaining visit documentation, resolving discrepancies, and ensuring compliance with applicable standards and regulations.
Job details
Senior CRA – Part-Time Contract 📍 Ontario or Quebec, Canada 🔬 Phase 1 Clinical Trials 🗣️ English & French Required We are seeking an experienced Senior CRA for a 6-month part-time contract supporting clinical research activities at a site in Quebec. Key Responsibilities 🔍 Conduct source data verification and review informed consent and regulatory documentation. 📋 Identify and resolve data discrepancies and compliance issues. 📑 Manage site documentation, contracts, and investigator files. 💵 Support site budget negotiations. ✅ Ensure compliance with ICH/GCP and applicable regulations. 📊 Maintain accurate visit documentation and escalate issues when needed. Requirements 🎓 5+ years of clinical research/CRA experience with independent site monitoring. 🧪 Phase 1 experience required. 💊 Experience with PK studies, healthy volunteers, or nephrology preferred. 🗣️ Fluent in English and French. 🇨🇦 Located in Ontario or Quebec. 📚 Strong knowledge of ICH/GCP and Canadian clinical trial requirements. 🎓 Bachelor's degree or equivalent experience. Interested? Reach out to learn more about this opportunity and see if it could be a good fit for your background!
What you’ll do
Conduct independent site monitoring, including source data verification and review of informed consent and regulatory documents. Manage site records, contracts, investigator files, and budget negotiations while maintaining visit documentation, resolving discrepancies, and ensuring compliance with applicable standards and regulations.
Requirements
Requires at least five years of clinical research or CRA experience, independent site monitoring experience, and Phase 1 trial experience. Candidates must be fluent in English and French, located in Ontario or Quebec, and have strong knowledge of ICH/GCP and Canadian clinical trial requirements; a bachelor's degree or equivalent experience is required.
Listed skills
- Clinical care · Preferred
- French · Preferred
- Budget · Preferred
- Compliance · Preferred
- Documentation · Preferred
- Communication · Preferred
- Site Documentation · Preferred
- contracts · Preferred
- Time · Preferred
- Google Cloud · Preferred
- Bilingual communication · Preferred
- English · Preferred
Other relevant skills
Identified from the job description. Confirm important requirements above.
- Independent Site Monitoring
- Source Data Verification
- Informed Consent Review
- Regulatory Documentation
- Data Discrepancy Resolution
- Compliance Issue Resolution
- Site Documentation Management
- Contract Management
- Investigator File Management
- Site Budget Negotiation
- ICH/GCP Compliance
- Clinical Trial Regulations
- Visit Documentation
- Issue Escalation
- Phase 1 Clinical Trials
- Pharmacokinetic Studies
Job areas
- Healthcare
- Science & Research