Clinical Research Associate
Clinical Research Associate (requires travel)
• The Clinical Research Associate is a site management and monitoring expert on the extended Global Study Team. The CRA is accountable and responsible for all aspects of site management and monitoring activities for assigned applicable Phase I – IV studies and clinical investigator sites within the approved Clinical Development Plan (CDP). These global, complex studies are conducted within the standard operating procedures set by the company, according to Good Clinical Practices (ICH-GCP), and applicable regulatory and legal requirements.
• The overall purpose of the CRA II is to verify that:
1. The rights and well-being of human subjects are protected.
2. The reported trial data are accurate, complete, and verifiable from source documents.
3. The conduct of the trials is in compliance with the currently approved protocol/amendment(s) with GCP, and with the applicable regulatory requirements. Working directly with the assigned study CLM to follow-up up outstanding items or issues with assigned sites. Monitoring investigator sites. Completing monitoring visit reports
Recommended experience in:
Cardiovascular (Heart Failure)
4+ years of field monitoring
Ability to work independently, prioritize and work efficiently
Preferences: (list nice-to-haves such a specific knowledge items, certifications, skills, abilities, etc.)
• Experience in clinical systems indicated below:
o Veeva Vault
o Microsoft Office-TEAMs, One Note
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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