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
