Senior Clinical Research Associate
Location
Germany
Posted
7 days ago
Salary
0
Seniority
Senior
Job Description
Senior Clinical Research Associate
Parexel
• 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, ensuring relevant timelines and quality deliverables are met. • 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, to bring SAE reports required information to resolution. • Serve as a point of contact for audit conduct, and drive Audit Observation CAPA development and checks, when applicable
Job 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
- Retirement plans
- Professional development opportunities
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