Clinical Research Associate II, Immunology

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

📋 Description

• Enhance AbbVie’s clinical research pipeline by promoting excellence in clinical research.

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

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

• Provide contextual information regarding clinical trials and facilitate connections between stakeholders and investigative sites.

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

• Conduct site evaluations, training sessions, routine onsite and offsite monitoring, and site closure monitoring.

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

• Develop and tailor site engagement strategies while tracking progress and impact.

• Collect local and site-specific insights.

• Assist in recruitment and retention strategies based on patient disease journeys.

• Maintain up-to-date knowledge of the therapeutic area, asset, clinical landscape, and patient journey.

• Mentor and train junior Clinical Research Associates (CRAs).

• Participate in global or local task forces and initiatives.

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

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

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

• Ensure the quality and timely submission of site data and safety-event reports.

• Maintain readiness for audits and regulatory inspections.

• Manage investigator payments in accordance with executed contract obligations.

⛳️ Requirements

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

• Valid driver's license.

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

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

• Understanding of therapeutic area indications and scientific concepts pertinent to clinical trials.

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

• Strong skills in cross-functional collaboration.

• Excellent planning and organizational abilities.

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

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

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

• Ability to build site relationships and foster trusted partnerships through engagement, motivation, and training.

• Critical thinking and sound judgment to address clinical site challenges.

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

• Self-motivated and dedicated to achieving timely, high-quality outcomes.

• Valid driver's license.

🏝️ Benefits

• Life assurance.

• Medical plan.

• Flexible benefits.

• Company car.

• Comprehensive total reward package.

• Well-being benefits.