Clinical Research Associate II

This is a fully remote position, open to applicants in Canada.

📋 Description

• Oversees activities carried out by clinical investigative sites related to AbbVie clinical studies to ensure the successful implementation of the protocol.

• Guarantees compliance with federal regulations and relevant local laws, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and quality standards in the execution of clinical research.

• Performs site qualification, initiation, interim monitoring, and study closeout visits for Phase I to III studies in line with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and business processes.

• Maintains readiness for regulatory inspections at designated clinical sites.

• Ensures the integrity of data submitted from study sites and guarantees timely data submission, including proper reporting and follow-up of all safety events by site personnel.

• Educates study site personnel on the protocol and relevant regulatory requirements in collaboration with key project team members.

• Continuously identifies, assesses, and recommends new or potential investigators/sites.

⛳️ Requirements

• A minimum of 2 years of experience in clinical monitoring.

• Proven experience in on-site monitoring of investigational drug or device trials is essential.

• Up-to-date and thorough understanding of regulations governing clinical research, ICH/GCP Guidelines, and applicable regulations.

• Familiarity with all facets of study monitoring, including data management, drug accountability, and documentation.

• Strong organizational and planning abilities.

• Capable of working efficiently in a fast-paced environment with multiple projects and deadlines.

• Proficient in addressing clinical site issues related to studies with appropriate guidance and initiating corrective actions as necessary.

• Willingness to travel at least 50% of the time.

• Proficient in Microsoft Office Suite (Outlook, PowerPoint, Excel, Word, etc.).

🏝️ Benefits

• Health insurance

• 401(k) matching

• Flexible working hours

• Paid time off