Clinical Research Associate II

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

📋 Description

• Oversee activities carried out by clinical investigative sites for AbbVie clinical trials

• Ensure adherence to protocols, federal and local regulations, GCPs, ICH Guidelines, AbbVie SOPs, monitoring plans, and quality standards

• Perform site qualification, initiation, interim monitoring, and study closeout visits for Phase I to III trials

• Supervise site personnel activities and implement strategies to guarantee compliance

• Maintain regulatory inspection readiness at assigned clinical sites

• Ensure the quality and timely submission of site data, including safety-event reporting and follow-up

• Safeguard study subjects by adhering to monitoring plans, SOPs, ICH Guidelines, and relevant regulations

• Train study site personnel on protocols and regulatory requirements

• Manage investigator payments and negotiate agreements with investigators and hospitals

• Complete expense reports

• Identify, assess, and recommend new investigators and clinical sites

⛳️ Requirements

• Preferred tertiary qualification in a health-related field, such as Medical, Scientific, or Nursing

• At least 2 years of relevant clinical monitoring experience

• Required experience with on-site monitoring of investigational drug or device trials

• Comprehensive understanding of therapeutic indications pertinent to clinical trials

• Extensive knowledge of clinical research regulations, ICH/GCP Guidelines, and applicable regulations

• Familiarity with study monitoring, data management, drug accountability, and documentation

• Strong planning and organizational abilities

• Capability to work efficiently in a fast-paced environment with multiple projects and deadlines

• Ability to comprehend and adhere to work processes

• Strong analytical and conceptual skills

• Effective interpersonal skills and clear communication abilities

• Competence in addressing clinical site issues and conveying corrective actions

• Ability to exercise sound judgment

• Proven business ethics and integrity

• Minimum 50% travel required

• Proficiency in Microsoft Office Suite, including Outlook, PowerPoint, Excel, and Word

• Comfortable using various technologies and systems for daily tasks

• Valid driver’s license and passport

🏝️ Benefits

• Option for remote work

• Commitment to equal opportunity employment

• Reasonable accommodations for applicants with disabilities