Clinical Research Associate II

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

📋 Description

• Proactively address and resolve clinical site issues related to studies while initiating, recommending, and communicating corrective measures.

• Oversee activities performed by clinical investigative sites involved in AbbVie clinical trials.

• Ensure compliance with federal and local regulations, Good Clinical Practices (GCP), International Conference on Harmonisation (ICH) Guidelines, AbbVie Standard Operating Procedures (SOPs), monitoring plans, and quality standards.

• Conduct site qualification, initiation, interim monitoring, and study closeout visits for Phase I to III studies.

• Supervise site personnel activities and motivate/influence them to achieve study objectives.

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

• Maintain readiness for regulatory inspections at assigned clinical sites.

• Guarantee the quality and timeliness of study-site data submissions, including reporting and follow-up on safety events.

• Ensure the safety and protection of study participants through adherence to monitoring plans, SOPs, guidelines, and regulations.

• Educate study site personnel on protocols and regulatory requirements.

• Administer investigator payments in accordance with executed contract obligations.

• Negotiate agreements with investigators and hospitals alongside relevant stakeholders.

• Complete and maintain expense reports in accordance with applicable guidelines.

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

⛳️ Requirements

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

• A minimum of 2 years of experience in clinically-related monitoring.

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

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

• Thorough understanding of regulations governing clinical research, as well as ICH/GCP Guidelines and applicable regulations.

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

• Strong planning and organizational abilities with a capacity to work effectively and efficiently in a dynamic environment with competing projects and deadlines.

• Capability to comprehend and follow work processes pertinent to the assigned function.

• Strong analytical and conceptual skills, along with excellent interpersonal abilities and clear communication.

• Ability to address study-related clinical site issues with appropriate guidance, initiating and communicating corrective actions as necessary.

• Proficiency in applying functional expertise and exercising sound judgment.

• Demonstrated business ethics and integrity.

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

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

• Comfortable with technology and adept at using various tools/systems for daily tasks.

• Possession of a valid driver’s license and passport.

🏝️ Benefits

• Innovative work culture.

• Opportunities for professional development.

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

• Employee stock purchase program.

• Wellness spending account.

• Flexible health insurance options.

• Retirement savings programs.

• Bonus plan.