Senior Clinical Research Associate conducting onsite monitoring and regulatory support for a global medical research company in Canada. Managing clinical - trial sites, CRFs, queries, audits, and study submissions.
About the role
- Clinical Research Associate II monitoring Phase I–III clinical trials for AbbVie, an innovative medicines company. Managing site compliance, data quality, safety reporting, and investigator relationships with at least 50% travel.
Responsibilities
- Monitor activities conducted by clinical investigative sites for AbbVie clinical studies
- Ensure protocol execution and adherence to federal and local regulations, GCPs, ICH Guidelines, AbbVie SOPs, monitoring plans, and quality standards
- Conduct site qualification, initiation, interim monitoring, and study closeout visits for Phase I to III studies
- Oversee site personnel activities and implement action plans to ensure compliance
- Ensure regulatory inspection readiness at assigned clinical sites
- Ensure quality and timely submission of site data, including safety-event reporting and follow-up
- Protect study subjects through compliance with monitoring plans, SOPs, ICH Guidelines, and applicable regulations
- Train study site personnel on protocols and regulatory requirements
- Manage investigator payments and negotiate investigator/hospital agreements
- Complete expense reports
- Identify, evaluate, and recommend new investigators and clinical sites
Requirements
- Appropriate tertiary qualification in a health-related field preferred, such as Medical, Scientific, or Nursing
- Minimum 2 years of clinically related monitoring experience
- Experience with on-site monitoring of investigational drug or device trials required
- In-depth knowledge of therapeutic indications relevant to clinical trials
- In-depth knowledge of clinical research regulations, ICH/GCP Guidelines, and applicable regulations
- Familiarity with study monitoring, data, drug accountability, and documentation
- Strong planning and organizational skills
- Ability to work effectively in a dynamic environment with competing projects and deadlines
- Ability to understand and follow work processes
- Strong analytical and conceptual capabilities
- Interpersonal skills and clear communication ability
- Ability to address clinical site issues and communicate corrective actions
- Ability to exercise good judgment
- Demonstrated business ethics and integrity
- Minimum 50% travel required
- Proficiency with Microsoft Office Suite, including Outlook, PowerPoint, Excel, and Word
- Comfort using various technologies and systems for day-to-day tasks
- Valid driver’s license and passport
Benefits
- Remote work option
- Equal opportunity employment
- Reasonable accommodation for applicants with disabilities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
No Education Requirement
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