Senior Initiation Clinical Research Associate
ParexelBellandur, BangalorePosted 25 days ago
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About the role
Parexel delivers clinical development and consulting services for the life sciences industry. The Clinical Research Associate manages clinical study startup, regulatory documentation, and site activation activities.
What you'll do
- Coordinate startup activities with assigned clinical sites
- Prepare and manage site qualification and confidentiality agreements
- Review regulatory documents and support site initiation readiness
- Submit IRB/IEC and regulatory authority applications
- Maintain trial master files and clinical trial management system records
- Resolve site issues and monitor activation risks
Skills
Must have
- Clinical trial startup
- Clinical trial methodology
- Ich-gcp
- Regulatory compliance
- Clinical trial management systems
- Electronic trial master files
- Site activation
- Regulatory document management
Nice to have
- Regulatory affairs
- Site management
- International regulatory requirements
- Multi-country study operations
Tools
- Microsoft office
Who it's for
- Education
- Bachelor's degree
- Degree
- biological science, pharmacy, health-related discipline, nursing
- Domain
- clinical research
About Parexel
Parexel has 18 open roles in Bangalore, at Parexel International - RMZ Ecoworld. See every Parexel role.
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