Clinical Research Associate, Senior - FSP
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Job Description
Clinical Research Associate managing clinical trials at various investigator sites for Parexel. Ensuring patient safety and quality study execution with strong regulatory compliance.
Responsibilities:
- Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan and applicable prevailing laws, Good Clinical Practices.
- Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through database lock.
- Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites.
- Monitor site level AEs and SAEs and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed.
Requirements:
- Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent
- Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations
- Minimum 3.5 years relevant experience in clinical research site monitoring (preferably in Oncology)
Benefits:
- Health insurance
- Flexible work arrangements
- Professional development
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