Clinical Research Associate I

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

📋 Description

• Propel AbbVie’s clinical research initiatives and facilitate the development of groundbreaking medicines for patients.

• Act as the main liaison for investigative sites.

• Offer contextual insights on clinical trials and link stakeholders with investigative sites.

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

• Execute site evaluations, training, routine monitoring, and closure activities.

• Ensure adherence to protocols, monitoring plans, regulations, Good Clinical Practices, ICH Guidelines, AbbVie SOPs, and quality standards.

• Tailor site engagement strategies for designated studies.

• Collect local and site insights and utilize CRM tools to monitor progress and assess impact.

• Relate study protocols, scientific principles, and clinical trial requirements to everyday operations.

• Assess recruitment and retention strategies based on the patient disease journey.

• Cultivate knowledge in therapeutic areas, assets, clinical landscapes, and patient journeys to enhance recruitment and protocol adherence.

• Mentor and train junior CRAs while providing development feedback.

• Engage in global or local task forces and initiatives.

• Conduct ongoing risk assessments with the Central Monitoring team to identify study performance or patient safety concerns.

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

• Identify, evaluate, and recommend potential investigators and sites.

• Guarantee quality and timely submission of site data, safety-event reporting, and follow-up.

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

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

⛳️ Requirements

• Relevant tertiary qualification in health-related fields (Medical, Scientific, Nursing) is preferred.

• At least 1 year of clinical experience is required.

• A minimum of 6 months of clinical research monitoring experience involving investigational drug or device trials is necessary.

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

• Knowledge of relevant therapeutic area indications is preferred.

• Capability to comprehend and apply scientific concepts to the execution of clinical trials.

• Advanced understanding of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies.

• Exceptional cross-functional collaboration skills with internal and external stakeholders.

• Strong organizational and planning skills; able to thrive in a dynamic environment with competing projects and deadlines.

• Advanced proficiency in utilizing technology, tools, and resources.

• Excellent interpersonal skills, including written, verbal, active listening, and presentation abilities.

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

• Ability to apply functional expertise, critical thinking, and sound judgment to resolve clinical site issues.

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

• Self-driven and focused on delivering timely, high-quality outcomes in a fast-paced environment.

🏝️ 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.