Clinical Research Associate II

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

📋 Description

• Propel AbbVie's clinical research pipeline by transforming scientific advancements into effective treatments.

• Act as the main liaison for investigative sites.

• Offer detailed information regarding clinical trials and facilitate connections between stakeholders and investigative sites.

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

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

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

• Tailor site engagement strategies and monitor their effectiveness using CRM tools.

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

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

• Mentor and guide less experienced Clinical Research Associates (CRAs).

• Engage in global and local task forces and initiatives.

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

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

• Identify and recommend investigators and sites for clinical trials.

• Ensure the quality of data and timely submissions, including safety-event reporting and follow-ups.

• Maintain readiness for audits and regulatory inspections.

• Manage investigator payments as necessary.

⛳️ Requirements

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

• At least 1 year of experience in clinically related roles, including a minimum of 6 months in clinical research monitoring of investigational drug or device trials.

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

• Knowledge of relevant therapeutic area indications is preferred.

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

• Excellent cross-functional collaboration skills.

• Strong planning and organizational abilities.

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

• Proficient in utilizing technology, tools, and resources for customer-centric site support.

• Exceptional written, verbal, active listening, and presentation skills.

• Ability to establish and leverage site relationships and build trusted partnerships.

• Skillful in applying critical thinking and sound judgment to resolve clinical site issues.

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

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

🏝️ Benefits

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

• Medical, dental, and vision insurance.

• 401(k) plan.

• Short-term incentive programs.

• Travel required: 75% of the time.