Functieomschrijving
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
Experience: years
Vacancy: 1