Senior CRA

Job summary

Monitor clinical trial activities, verify source data, review consent and regulatory records, and resolve data discrepancies and protocol compliance issues. Manage site documentation, contracts, budget negotiations, and monitoring records while ensuring compliance with study protocols, ICH-GCP, and applicable regulations.

Job details

Overview Seeking an experienced, French-speaking Senior Clinical Research Associate (CRA) to support clinical trial monitoring, site management, regulatory documentation, and budget negotiations for a clinical research organization. This is a 6-month, part-time contract opportunity supporting a clinical trial site in Quebec. The ideal candidate will have 5+ years of clinical research experience, Phase I study experience, and a strong understanding of GCP and clinical trial regulations. Key Responsibilities Conduct source data verification by comparing Case Report Forms (CRFs) against source documentation. Review Informed Consent Forms, regulatory documents, and device accountability records for accuracy and completeness. Identify, investigate, document, and resolve data discrepancies and protocol non-compliance issues. Ensure reportable events are appropriately documented and escalated in accordance with protocol requirements and applicable regulations. Manage study contracts and collect, review, and approve essential investigator and site documentation. Coordinate regulatory documentation, including financial disclosure forms, CVs, and medical licenses. Conduct site budget negotiations and support ongoing site management activities. Maintain thorough documentation of monitoring activities, findings, and issue resolution. Ensure compliance with ICH-GCP guidelines, applicable regulatory requirements, and study protocols. Independently manage priorities and multiple responsibilities while supporting clinical trial quality and integrity. Required Skills Bachelor's degree in a clinical, biological, scientific, or health-related field, or an equivalent combination of education, training, and experience. 5+ years of clinical research experience, including independent onsite monitoring and clinical trial site management, or demonstrated experience performing the core responsibilities of the role. Experience supporting Phase I clinical trials. Fluency in both English and French. Must be located in Ontario or Quebec, Canada. Strong knowledge of ICH-GCP, clinical trial regulations, and applicable country-specific requirements. Strong analytical, organizational, and problem-solving skills. Ability to work independently, manage competing priorities, and maintain accurate documentation. Excellent communication and interpersonal skills. Preferred Skills Experience in pharmacokinetics (PK) studies. Experience supporting healthy volunteer studies. Experience in nephrology clinical trials. Familiarity with ISO 14155 requirements. Experience with clinical trial regulatory documentation, site contracts, and budget negotiations. Position Details Location: Canada; supporting one clinical trial site in Quebec Eligibility: Must reside in Ontario or Quebec Duration: 6 months Schedule: Part-time (0.5 FTE) Language: Fluent French and English

What you’ll do

Monitor clinical trial activities, verify source data, review consent and regulatory records, and resolve data discrepancies and protocol compliance issues. Manage site documentation, contracts, budget negotiations, and monitoring records while ensuring compliance with study protocols, ICH-GCP, and applicable regulations.

Requirements

Requires a bachelor's degree in a relevant field or equivalent education, training, and experience, at least five years of clinical research experience, and Phase I trial experience. Candidates must be fluent in English and French, reside in Ontario or Quebec, and have strong knowledge of ICH-GCP and clinical trial regulations.

Listed skills

• French · Preferred
• Budget · Preferred
• Training · Preferred
• Compliance · Preferred
• management · Preferred
• Documentation · Preferred
• Accuracy · Preferred
• Site Documentation · Preferred
• contracts · Preferred
• Time · Preferred
• Google Cloud · Preferred
• English · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Clinical Trial Monitoring
• Source Data Verification
• Site Management
• Phase I Clinical Trials
• ICH-GCP
• Regulatory Documentation
• Informed Consent Review
• Data Discrepancy Resolution
• Protocol Compliance
• Site Contract Management
• Budget Negotiation
• Clinical Trial Regulations
• French Fluency
• English Fluency
• Pharmacokinetics
• Healthy Volunteer Studies

Job areas

• Healthcare
• Science & Research
• Management & Leadership

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