Clinical Research Associate II, Oncology

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

📋 Description

• Propel AbbVie’s oncology clinical research initiatives and assist in the execution of clinical trials.

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

• Act as the main Sponsor liaison for investigative sites.

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

• Align, train, and inspire site staff and principal investigators on 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, GCPs, ICH Guidelines, SOPs, and quality standards.

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

• Collect local and site insights and report on progress using site engagement tools.

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

• Acquire knowledge of therapeutic areas, assets, clinical landscapes, and patient journeys.

• Mentor and train less experienced Clinical Research Associates (CRAs).

• Engage in global or local task forces and initiatives.

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

• Identify and address site risk signals, implementing preventative and corrective action plans.

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

• Ensure data integrity and prompt submission, including safety-event reporting and follow-up.

• Maintain readiness for audits and regulatory inspections.

• Manage investigator payments as necessary.

⛳️ Requirements

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

• Valid driver’s license.

• A minimum of 1 year of experience in a clinically related role.

• At least 6 months of experience in clinical research monitoring of investigational drug or device trials.

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

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

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

• Strong skills in cross-functional collaboration.

• Excellent planning and organizational abilities.

• Capacity to work efficiently in a dynamic environment with multiple projects and deadlines.

• Capability to leverage technology, tools, and resources effectively.

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

• Ability to establish and foster relationships and trusted partnerships with sites.

• Proficiency in applying critical thinking and sound judgment to resolve clinical site issues.

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

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

• Willingness and ability to travel approximately 75% of the time.

🏝️ Benefits

• Life assurance.

• Medical plan.

• Flexible benefits.

• Company car.

• Comprehensive total reward package.

• Well-being benefits.