Senior Clinical Research Associate

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

📋 Description

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

• Collaborate with study teams, internal research and development stakeholders, investigators, and site personnel.

• Act as the primary point of contact for the investigative site on behalf of the sponsor.

• Provide context for trials, connect stakeholders with investigative sites, and enhance AbbVie’s partnerships in clinical trials.

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

• Mentor and guide junior Clinical Research Associates (CRAs) and assist with local onboarding processes.

• Execute site evaluations, conduct site training, perform regular on-site and off-site monitoring, and oversee site closure monitoring.

• Ensure adherence to protocols, monitoring plans, regulations, Good Clinical Practices (GCPs), International Council for Harmonisation (ICH) Guidelines, Standard Operating Procedures (SOPs), and quality standards.

• Formulate and implement site engagement strategies; collect local/site insights and assess the impact of these strategies.

• Develop techniques for recruitment and retention based on the patient disease journey.

• Carry out continuous risk assessments with the Central Monitoring team to identify issues related to study performance and patient safety.

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

• Ensure the quality and timely 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 executed contract obligations, where applicable.

• Participate in or lead global and local task forces and initiatives.

• Undertake additional tasks as assigned by the manager.

⛳️ Requirements

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

• A minimum of 3 years of experience in clinically related roles.

• Ideally, 2 years of independent clinical research monitoring experience for investigational drug or device trials.

• Familiarity with risk-based monitoring, including both onsite and offsite methods.

• Knowledge of therapeutic-area indications and the ability to apply scientific concepts in clinical trial execution.

• Strong understanding of local regulatory and legal requirements, ICH/GCP Guidelines, and relevant policies.

• Exceptional communication and cross-functional collaboration skills.

• Excellent planning and organizational abilities; capable of managing competing projects and deadlines.

• Proficiency in utilizing technology, tools, and resources for customer-focused site support.

• Strong interpersonal, written, verbal, active listening, and presentation skills.

• Capacity to build site relationships and establish trusted partnerships through engagement, motivation, and training.

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

• Integrity in alignment with AbbVie’s code of business conduct and leadership values.

• Self-driven focus on achieving timely, quality outcomes in a dynamic environment.

🏝️ 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.