Clinical Research Associate II, Immunology

🔥 4 minutes ago

🇮🇹 Italy – Remote

💵 €46.5k - €73.5k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 0%

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AbbVie

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2013

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

AbbVie is a global pharmaceutical company that discovers and delivers innovative medicines and solutions to enhance lives. With a focus on addressing the world's toughest health challenges, AbbVie operates in over 175 countries, providing a wide range of products across areas like immunology, oncology, neuroscience, and aesthetics. Committed to scientific innovation, AbbVie invests heavily in research and development, aiming to produce first-in-class medicines. The company also emphasizes workplace diversity, sustainability, and patient support initiatives, ensuring positive impact for both its patients and the broader community.

📋 Description

• Advance AbbVie’s clinical research pipeline by supporting excellence in clinical research • Partner with study teams, internal R&D stakeholders, investigators, and site staff • Serve as the primary Sponsor point of contact for investigative sites • Provide contextual information on clinical trials and connect stakeholders with investigative sites • Align, train, and motivate site staff and principal investigators on trial goals, protocols, and patient treatment principles • Conduct site evaluation, site training, routine onsite and offsite monitoring, and site closure monitoring • Ensure compliance with protocols, monitoring plans, regulations, GCPs, ICH Guidelines, SOPs, and quality standards • Develop and customize site engagement strategies and track progress and impact • Gather local and site insights • Support recruitment and retention plans based on patient disease journeys • Maintain knowledge of the therapeutic area, asset, clinical landscape, and patient journey • Mentor and train less experienced CRAs • Participate in global or local task forces and initiatives • Conduct continuous risk assessment with the Central Monitoring team • Resolve site risk signals and implement preventative and corrective action plans • Identify, evaluate, and recommend investigators and sites • Ensure quality and timely submission of site data and safety-event reporting • Maintain audit and regulatory inspection readiness • Manage investigator payments according to executed contract obligations

🎯 Requirements

• Bachelor’s degree or equivalent degree; health related preferred (e.g. Medical, Scientific, Nursing, Pharmacy) • Valid driver’s license • Minimum of 1 year of clinically related experience, including 6 months in clinical research monitoring of investigational drug or device trials • Familiarity with risk-based monitoring, onsite and offsite monitoring • Knowledge of therapeutic area indications and scientific concepts related to clinical trials • Advanced knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies • Strong cross-functional collaboration skills • Strong planning and organizational skills • Ability to work effectively in a dynamic environment with competing projects and deadlines • Ability to leverage technology, tools, and resources for customer-centric site support • Strong interpersonal, written, verbal, active listening, and presentation skills • Ability to establish site relationships and trusted partnerships through engagement, motivation, and training • Critical thinking and good judgment to address clinical site issues • Integrity in accordance with AbbVie’s code of business conduct and leadership values • Self-motivated and focused on timely, quality outcomes • Valid driver’s license

🏖️ Benefits

• Life assurance • Medical plan • Flexible benefits • Company car • Comprehensive total reward package • Well-being benefits