Experienced CRA - Denmark
IQVIA
IQVIA seeks an experienced Clinical Research Associate to conduct monitoring and site management activities for clinical studies in Denmark. The role involves monitoring visits, protocol training, data integrity oversight, and coordination with study sites to ensure compliance with regulations and sponsor requirements.
Responsibilities
- Conduct site selection, initiation, monitoring, and close-out visits per protocol and GCP standards
- Collaborate with sites on subject recruitment planning and progress tracking
- Deliver protocol training and maintain ongoing communication with study sites
- Monitor study data quality, protocol adherence, and regulatory compliance; escalate issues as needed
- Manage study documentation, CRF submissions, data queries, and regulatory submissions tracking
Requirements
- Bachelor's degree in scientific or healthcare discipline preferred
- Minimum 2 years of on-site clinical monitoring experience
- Knowledge of Good Clinical Practice (GCP) and ICH guidelines
- Proficiency in Microsoft Word, Excel, PowerPoint, and mobile devices
- Fluency in Danish and English, both written and verbal
- Strong organizational, problem-solving, and time management skills
- Ability to build effective working relationships with diverse stakeholders
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