Novotech is seeking a Clinical Research Associate to perform site evaluations, maintain documentation according to GCP, and support recruitment and initial setup of projects. The role involves quality assurance, data management, and communication with sites and regulatory bodies. They offer a supportive and inclusive workplace with flexible work options and employee growth opportunities.
Requirements
- Performing site evaluation, initiation, monitoring, and close-out visits.
- Maintaining appropriate documentation according to a project-specific monitoring plan, ICH-GCP.
- Supporting the development of a subject recruitment plan.
- Evaluating the quality and integrity of site practices.
- Managing progress by tracking regulatory submissions, recruitment, and data query resolution.
- Assist with country/site ICF development, IRB submission package preparation, site contract and budget negotiation, and regulatory document collection.
Benefits
- Flexible working options
- Paid parental leave
- Flexible leave entitlements
- Wellness programs
- Ongoing development programs