Clinical Research Associate
Job Summary
AbbVie is looking for a Clinical Research Associate (CRA) to support clinical studies in Belgium. The role partners with investigators and site teams to promote effective study delivery data quality compliance and a positive site experience.
Key Responsibilities
- Serve as the primary point of contact for assigned investigative sites providing relevant study information and coordinating with internal stakeholders.
- Build effective working relationships with investigators and site staff and support their understanding of the study objectives protocol and patient treatment principles.
- Conduct site evaluation initiation routine monitoring and close-out activities in accordance with the protocol monitoring plans applicable regulations GCP ICH Guidelines AbbVie SOPs and quality standards.
- Support the safety and protection of study participants throughout the clinical trial.
- Develop and adapt site engagement strategies based on study requirements and local site insights using available tools to track progress and measure impact.
- Apply knowledge of the protocol scientific principles therapeutic area and patient journey to support recruitment retention and protocol compliance.
- Conduct ongoing risk assessments and collaborate with the Central Monitoring team to identify potential study performance or patient safety issues.
- Investigate site risk signals and ensure appropriate preventive and corrective action plans are implemented when required.
- Ensure the quality and timely submission of data and safety information by site personnel while maintaining audit and inspection readiness.
- Identify and recommend potential investigators and sites contribute to assigned initiatives and support the development of less experienced CRAs through mentoring and training.
Qualifications :
- Degree or equivalent qualification in a health-related discipline such as Medicine Life Sciences Nursing or a related scientific field.
- At least one year of clinically related experience including a minimum of six months of experience in clinical research monitoring of investigational drug or device trials.
- Familiarity with risk-based monitoring approaches including on-site and remote monitoring.
- Knowledge of relevant therapeutic areas and the ability to apply scientific concepts to clinical trial conduct.
- Knowledge of local regulatory and legal requirements ICH/GCP Guidelines and applicable policies.
- Fluency in French Dutch and English is required.
- Strong collaboration communication active listening and presentation skills with the ability to build effective relationships with investigators and site teams.
- Strong planning and organizational skills with the ability to manage competing priorities and deadlines.
- Ability to use technology monitoring tools and available resources to support site engagement and study execution.
- Ability to apply sound judgment critical thinking and functional expertise when addressing clinical site issues.
- Self-motivated and quality-focused with a commitment to integrity and compliance with AbbVies Code of Business Conduct and Leadership Values.
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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Yes
Employment Type :
Full-time
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more