Clinical Research Associate

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

📋 Description

• Act as the main contact for designated investigative sites.

• Share pertinent study information and collaborate with internal stakeholders.

• Establish strong working relationships with investigators and site personnel.

• Aid in comprehending study objectives, protocols, and patient treatment principles.

• Carry out site evaluations, initiations, routine monitoring, and close-out activities.

• Ensure the safety and protection of study participants during clinical trials.

• Formulate and modify site engagement strategies based on study needs and local site insights.

• Monitor site engagement progress and evaluate its impact using available tools.

• Utilize knowledge of protocols, scientific principles, therapeutic areas, and patient journeys to enhance recruitment, retention, and protocol adherence.

• Perform continuous risk assessments in collaboration with the Central Monitoring team.

• Detect study performance or patient safety concerns and investigate site risk indicators.

• Guarantee the execution of preventive and corrective action plans when necessary.

• Ensure prompt and high-quality submission of data and safety information by site staff.

• Maintain readiness for audits and inspections.

• Identify and suggest potential investigators and sites.

• Contribute to designated initiatives.

• Mentor and train less experienced Clinical Research Associates.

⛳️ Requirements

• Degree or equivalent qualification in a health-related field, such as Medicine, Life Sciences, Nursing, or a related scientific discipline.

• A minimum of one year of clinically related experience.

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

• Familiarity with risk-based monitoring methodologies, including both on-site and remote monitoring.

• Understanding of relevant therapeutic areas and the ability to apply scientific concepts to the conduct of clinical trials.

• Awareness of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies.

• Proficiency in French, Dutch, and English is mandatory.

• Excellent collaboration, communication, active listening, and presentation skills.

• Strong planning and organizational abilities, with the capacity to manage competing priorities and deadlines.

• Capability to utilize technology, monitoring tools, and available resources to foster site engagement and study execution.

• Ability to exercise sound judgment, critical thinking, and functional expertise when addressing clinical site challenges.

• Self-driven and quality-focused, committed to integrity and compliance with AbbVie's Code of Business Conduct and Leadership Values.

🏝️ Benefits

• Employees can work remotely.

• Equal opportunity employer.

• Commitment to operating with integrity, fostering innovation, transforming lives, and serving the community.