Clinical Research Associate II – Montreal
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Job Description
Clinical Research Associate conducting compliance checks in clinical trials for pharmaceutical clients. Involvement includes remote visits and proactive communication with investigational sites for data accuracy.
Responsibilities:
- Conduct remote or on-site visits to assess protocol and regulatory compliance
- Manage procedures and guidelines from different sponsors
- Ensure audit readiness and develop collaborative relationships with investigational sites
- Apply root cause analysis and problem-solving skills to identify site processes failure
- Document observations in reports and letters in a timely manner
- Maintain contact between monitoring visits with investigative sites
- Conduct monitoring tasks in accordance with the approved monitoring plan
- Ensure a shared responsibility with other project team members on issue resolution
Requirements:
- Bachelor's degree in a life sciences related field or a Registered Nursing certification
- Previous experience comparable to 1 year as a clinical research monitor or completion of PPD Drug Development Fellowship
- Valid driver's license where applicable
- Proven clinical monitoring skills
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
- Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents
- Well-developed critical thinking skills
- Good oral and written communication skills in English and French
Benefits:
- Flexible work arrangements
- Professional development opportunities
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