Senior Clinical Research Associate – Sponsor Dedicated
Parexel
full-time
Posted on:
Location Type: Remote
Location: Germany
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Job Level
Tech Stack
About the role
- 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
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)
- Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
Benefits
- Health insurance
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trial methodologiessite monitoringGood Clinical PracticesICH guidelinesFDA regulationsdata managementaudit conductCAPA developmentadverse event monitoringsafety reporting
Soft Skills
communicationcollaborationorganizational skillsproblem-solvinginterpersonal skillsfacilitationtime managementleadership
Certifications
Bachelor’s degree in life sciencesprofessional degree in life sciences