Role and Responsibilities:
- Primary Contact: Serve as the main point of contact between site staff and Novo Nordisk, acting as an ambassador for the company.
- Site Management: Lead site management for the selection, initiation, conduction, and closure activities of studies, ensuring compliance with local regulations, ICH-GCP, NN procedures, and protocol requirements.
- Recruitment and Results: Responsible for recruitment at the site level and delivering results that impact the successful completion of the clinical program.
- Coordination: Coordinate with CRM and RTM, communicating progress and critical issues that may affect trial progress.
- Site Visits: Conduct efficient and accurate site selection visits, including analysis of site logistics and performance.
- Patient Recruitment: Develop and implement patient recruitment strategies and mitigation actions.
- Monitoring Activities: Regularly visit trial sites to perform required monitoring activities.
- IT Systems: Use IT systems (e.g., IMPACT, EDC) proactively for site visit preparation, conduct, and source data verification in collaboration with the data management/logistics team.
Qualifications:
- Education: Graduate in Medicine, Science, Pharmacy, or another relevant field.
- Certifications: Certified in ICH GCP; additional qualifications in clinical research preferred.
- Experience: 2-4 years as a Clinical Research Associate, with experience in 1-2 multinational clinical trials (phase 2-3) from site initiation to closure.
