Clinical Research Associate II

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

📋 Description

• Propel AbbVie’s clinical development pipeline by enhancing excellence in clinical research.

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

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

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

• Perform site evaluations, training, routine monitoring, and closure assessments.

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

• Create and tailor site engagement strategies for designated studies.

• Collect site insights and utilize CRM tools to report and track progress and assess impact.

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

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

• Enhance knowledge of therapeutic areas, assets, clinical landscapes, and patient journeys.

• Mentor and train less experienced CRAs while contributing to their professional growth.

• Engage in global or local task forces and initiatives.

• Conduct ongoing risk assessments in collaboration with the Central Monitoring team.

• Identify study-performance or patient-safety concerns and address site risk signals.

• Implement proactive and corrective action plans to reduce risk and enhance compliance.

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

• Ensure the quality and prompt submission of site data and safety-event reporting.

• Maintain audit and regulatory inspection readiness at assigned sites.

• Oversee investigator payments as necessary.

⛳️ Requirements

• At least 1 year of experience in a clinically related field.

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

• Knowledge of risk-based monitoring, both onsite and offsite.

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

• Preferred knowledge of appropriate therapeutic area indications.

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

• Excellent cross-functional collaboration skills.

• Strong planning and organizational abilities.

• Capability to operate effectively in a dynamic environment with competing projects and deadlines.

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

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

• Ability to establish and cultivate site relationships and trusted partnerships.

• Capacity to apply critical thinking and sound judgment to address clinical site challenges.

• Self-driven and focused on achieving timely, high-quality outcomes.

• Conducts oneself with integrity in alignment with AbbVie’s code of business conduct and leadership values.

🏝️ Benefits

• Paid time off (vacation, holidays, sick leave).

• Medical, dental, and vision insurance.

• 401(k) plan.

• Short-term incentive programs.

• Equal opportunity employer.

• Reasonable accommodations for applicants in the US & Puerto Rico.