Immunology Clinical Research Associate II

AbbVie; Roma; In loco; EUR 55.000 - 75.000; Tempo pieno

Descrizione del lavoro

AbbVie in Rome seeks a Clinical Research Associate to advance AbbVie’s pipeline by ensuring compliant site conduct, data integrity, and patient safety across trials in immunology, oncology, and neuroscience.

You will partner with study teams and investigators, provide site training, monitor trials, and mentor junior CRAs, contributing to global studies and risk-based monitoring improvements.

Competenze

• Bachelor’s degree or equivalent; health related preferred.
• 1 year clinically related experience, including 6 months in clinical research monitoring.
• Familiar with risk-based monitoring approach, onsite and offsite monitoring.
• Knowledge of therapeutic area indications and ability to apply scientific concepts to trials.
• Advanced knowledge of ICH/GCP guidelines and applicable policies.
• Strong cross-functional collaboration, planning and organizational skills.
• Ability to leverage technology and resources to provide customer-centric support for site health.
• Strong interpersonal and communication skills; able to present and build site relationships.
• Integrity and self-motivation in a fast-paced environment.

Mansioni

• Advance AbbVie's pipeline by striving for excellence in clinical research and leveraging advanced capabilities.
• Partner with study teams, AbbVie internal R&D stakeholders, investigators, and site staff for meaningful engagements.
• Focus on site clinical research ensuring proper conduct, data integrity, compliance, and overall study performance.
• Serve as primary Sponsor contact for the investigative site and provide contextual information on trials.
• Align/train/motivate site staff and principal investigators on trial goals and treatment principles.
• Conduct site evaluation, training, monitoring, and site closure activities per protocol and SOPs.
• Develop advanced site engagement strategies and report progress using engagement tools.
• Mentor and train less experienced CRAs; participate in global/local task forces as needed.
• Proactively assess risks with Central Monitoring and implement corrective actions to ensure safety and quality.
• Identify, evaluate and recommend new investigators/sites for planned studies.
• Ensure quality of data and timely reporting of safety events; audit and regulatory readiness.
• Manage investigator payments per contract obligations.

Conoscenze

Clinical monitoring

Cross-functional collaboration

Planning and organization

Regulatory knowledge

Technology proficiency

Communication skills

Integrity

Self-motivation

Analytical thinking

Formazione

Bachelor’s degree or equivalent

Descrizione del lavoro

AbbVie in Rome seeks a Clinical Research Associate to advance AbbVie’s pipeline by ensuring compliant site conduct, data integrity, and patient safety across trials in immunology, oncology, and neuroscience.

You will partner with study teams and investigators, provide site training, monitor trials, and mentor junior CRAs, contributing to global studies and risk-based monitoring improvements.