Clinical Research Associate II

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

📋 Description

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

• Provide relevant information regarding clinical trials and link stakeholders with investigative sites.

• Align, educate, and inspire site staff and principal investigators on the objectives of clinical trials, protocols, and patient treatment principles.

• Perform site evaluations, training, routine monitoring, and site closure tasks in accordance with protocols, regulations, GCPs, ICH Guidelines, SOPs, and quality standards.

• Tailor site engagement strategies and collect local/site insights.

• Utilize CRM tools to document and monitor progress while assessing the impact of strategies.

• Relate study protocols, scientific principles, and clinical trial requirements to the execution of daily trial activities.

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

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

• Mentor and provide training to less experienced Clinical Research Associates (CRAs).

• Engage in global/local task forces and initiatives.

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

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

• Identify and assess potential investigators and sites.

• Guarantee the quality and timely submission of site data and safety-event reporting.

• Maintain readiness for audits and regulatory inspections.

• Oversee investigator payments as per executed contracts.

⛳️ Requirements

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

• A minimum of 1 year of experience related to clinical settings.

• At least 6 months of experience in clinical research monitoring for investigational drug or device trials.

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

• Knowledge of therapeutic area indications is preferred.

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

• Strong skills in cross-functional collaboration, planning, organization, interpersonal communication, written and verbal communication, active listening, and presentation.

• Ability to utilize technology, tools, and resources effectively.

• Capacity to apply critical thinking and sound judgment to resolve clinical site issues.

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

• Self-driven and capable of delivering high-quality results in a fast-paced environment.

🏝️ Benefits

• Paid time off including vacation, holidays, and sick leave.

• Medical, dental, and vision insurance.

• 401(k) plan.

• Short-term incentive programs.

• Option for remote work.

• Equal opportunity employer benefits for veterans and disabled applicants.