Clinical Research Associate II, Immunology

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

📋 Description

• Propel AbbVie’s clinical research pipeline and facilitate the development of innovative medications.

• Collaborate with study teams, internal R&D stakeholders, investigators, and site personnel.

• Act as the primary point of contact for investigative sites on behalf of the Sponsor.

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

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

• Execute site evaluations, training, routine on-site and off-site monitoring, and site closure monitoring.

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

• Create and tailor site engagement strategies while monitoring their effectiveness.

• Collect local and site-specific insights.

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

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

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

• Engage in global or local task forces and initiatives.

• Conduct ongoing risk assessments with the Central Monitoring team.

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

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

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

• Maintain readiness for audits and regulatory inspections.

• Manage investigator payments in accordance with executed contracts, where applicable.

⛳️ Requirements

• Bachelor’s degree or equivalent; health-related fields preferred (e.g., Medical, Scientific, Nursing, Pharmacy).

• Valid driver’s license.

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

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

• Knowledge of therapeutic area indications and scientific concepts associated with clinical trials.

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

• Strong skills in cross-functional collaboration.

• Excellent planning and organizational abilities.

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

• Proficiency in leveraging technology, tools, and resources for customer-oriented site support.

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

• Ability to establish and utilize site relationships through engagement, motivation, and training.

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

• Commitment to acting with integrity in accordance with AbbVie’s code of business conduct and leadership values.

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

• Willingness to travel 75% of the time.

🏝️ Benefits

• Life assurance.

• Medical plan.

• Flexible benefits.

• Company car.

• Comprehensive total rewards package including compensation, well-being, and benefits.