Clinical Research Associate II, Oncology – Field Role

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

📋 Description

• Propel AbbVie’s oncology clinical research initiatives and enhance clinical trial excellence.

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

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

• Provide relevant clinical trial information and facilitate connections between stakeholders and investigative sites.

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

• Conduct evaluations of sites, provide training, perform routine on-site and off-site monitoring, and oversee site closure monitoring.

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

• Develop and tailor site engagement strategies while tracking their effectiveness.

• Collect local and site-specific insights utilizing engagement tools.

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

• Mentor and train junior CRAs and support their professional growth.

• 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 implement preventative and corrective action plans.

• Identify and evaluate prospective investigators and sites.

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

• Maintain readiness for audits and regulatory inspections at assigned sites.

• Oversee investigator payments as per executed contract obligations.

⛳️ Requirements

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

• Valid driver’s license required.

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

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

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

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

• Strong skills in cross-functional collaboration.

• Excellent planning and organizational abilities.

• Capability to operate effectively in a fast-paced environment with competing projects and deadlines.

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

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

• Ability to foster site relationships and build 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-driven and focused on achieving timely, quality results.

• Willingness to travel up to 75% of the time.

🏝️ Benefits

• Life assurance.

• Medical plan.

• Flexible benefits.

• Company car.

• Comprehensive total rewards package.

• Well-being benefits.