Senior Clinical Research Associate

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

📋 Description

• Enhance AbbVie's clinical research pipeline by facilitating clinical trials and converting scientific findings into medical applications.

• Collaborate with study teams, internal R&D stakeholders, investigators, and site personnel.

• Act as the main point of contact for investigative sites on behalf of the sponsor.

• Align, educate, and inspire site staff and principal investigators regarding trial objectives, protocols, and patient treatment principles.

• Guide and support junior CRAs in site management activities and clinical research tasks.

• Conduct site evaluations, provide training, perform regular on-site and off-site monitoring, and oversee site closure monitoring.

• Ensure adherence to trial protocols, monitoring plans, regulations, GCP, ICH Guidelines, SOPs, and quality standards.

• Create and implement tailored site engagement strategies; collect site feedback and monitor the effectiveness of strategies.

• Assist with recruitment and retention efforts based on the patient's disease journey.

• Engage in or lead both global and local task forces and initiatives.

• Carry out ongoing risk assessments with the Central Monitoring team to identify study performance and patient safety concerns.

• Address site risk signals and execute preventative and corrective action plans.

• Identify, assess, and recommend investigators and sites for clinical studies.

• Ensure timely and high-quality submission of site data, including safety-event reporting and follow-ups.

• Maintain readiness for audits and regulatory inspections at assigned sites.

• Oversee investigator payments in accordance with contract obligations, when applicable.

⛳️ Requirements

• At least 3 years of clinically relevant experience; ideally, 2 years in independent clinical research monitoring of investigational drug or device trials.

• A relevant tertiary qualification in a health-related field such as Medicine, Science, Pharmacy, or Nursing is preferred, although not mandatory.

• Knowledge of risk-based monitoring and on-site/off-site monitoring practices.

• Understanding of therapeutic-area indications and the capacity to apply scientific concepts within clinical trials.

• Extensive knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and relevant policies.

• Advanced communication skills and ability to collaborate across functions.

• Exceptional planning and organizational abilities; capable of managing multiple projects and deadlines effectively.

• Proficiency in utilizing technology, tools, and resources for site support that prioritizes customer needs.

• Excellent skills in writing, verbal communication, active listening, and presentations.

• Capability to foster site relationships and build trusted partnerships through engagement, motivation, and training.

• Ability to independently apply functional expertise, critical thinking, and sound judgment to clinical site challenges.

• Integrity that aligns with AbbVie’s code of business conduct and leadership values.

• A self-driven approach focused on achieving timely, quality outcomes in a dynamic environment.

🏝️ Benefits

• Innovative work culture

• Professional development

• Paid time off: vacation, holidays, personal days, and volunteer days

• Employee stock purchase

• Wellness spending account

• Flexible health insurance

• Retirement savings programs

• Bonus plan