Clinical Research Associate II – GTA

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

📋 Description

• Anticipate and proactively address issues related to clinical study sites.

• Initiate, suggest, and communicate corrective measures for effective protocol-level execution of Clinical Site Management deliverables.

• Oversee activities conducted by clinical investigative sites involved in AbbVie clinical studies.

• Ensure compliance with 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 studies.

• Supervise site personnel activities and inspire them to achieve study objectives.

• Actively manage sites and execute action plans to guarantee compliance.

• Maintain regulatory inspection readiness at designated clinical sites.

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

• Safeguard the safety and welfare of study participants.

• Educate study-site personnel on protocols and regulatory requirements.

• Administer investigator payments in accordance with executed contracts.

• Negotiate agreements with investigators and hospitals alongside stakeholders.

• Complete expense reports in line with local and applicable guidelines.

• Identify, assess, and recommend new or potential investigators and sites.

⛳️ Requirements

• Relevant tertiary qualification in a health-related field (e.g., Medical, Scientific, Nursing) is preferred.

• At least 2 years of experience in clinically-related monitoring is required.

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

• Up-to-date knowledge and understanding of relevant therapeutic indications related to the conduct of clinical trials.

• Comprehensive knowledge of regulations governing clinical research, ICH/GCP Guidelines, and applicable laws.

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

• Strong organizational and planning skills, with the ability to work effectively in a dynamic environment characterized by competing projects and deadlines.

• Capability to navigate and adhere to work processes within the assigned function.

• Excellent analytical, conceptual, and interpersonal skills.

• Ability to communicate with clarity and precision.

• Skill in addressing study-related clinical site issues with appropriate guidance and initiating corrective actions as required.

• Ability to apply functional expertise and exercise sound judgment.

• Proven business ethics and integrity.

• Willingness to travel a minimum of 50% of the time.

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

• Comfortable with technology and adept at using various tools and systems to perform daily tasks.

• Valid driver's license and passport are necessary.

🏝️ Benefits

• Innovative work culture.

• Opportunities for professional development.

• Paid time off including vacation, holidays, personal days, and volunteer days.

• Employee stock purchase options.

• Wellness spending account.

• Flexible health insurance plans.

• Retirement savings programs.

• Bonus plan.