Senior Clinical Research Associate II – FSP
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Job Description
Senior Clinical Research Associate overseeing clinical trials in an FSP model. Ensuring compliance and quality in clinical research operations for drug development at Parexel.
Responsibilities:
- Oversight of Monitoring Responsibilities and Study Conduct
- Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client standards to achieve project goals, timelines and quality
- Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock
- Serve as the primary point of contact for assigned investigator sites during study conduct
- Facilitate information flow between members of the study team, vendors and assigned investigator sites
- Perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol
Requirements:
- Minimum 5 years relevant experience in clinical research site monitoring (preferably 3 years in Oncology)
- Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
- Must be fluent in English and in the native language(s) of the country they will work in
Benefits:
- Health insurance
- Professional development opportunities
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