Clinical Research Associate
tfscro
- Seniority
- Junior
About the role
About this role
Key Responsibilities
Independently plan, conduct, and follow up on pre-study, site initiation, routine monitoring, and close-out visits, both on-site and remotely, in line with the monitoring plan
Oversee study site performance, including recruitment progress, and support sites with study-related questions and operational challenges within Phase II–III trials
Review eCRF data, timelines, and queries; identify and report protocol deviations; and maintain clear communication with project management and sponsors
Maintain and review study documentation at site level, including Investigator Site Files (ISF), ensuring inspection readiness and compliance with applicable regulations
Collaborate cross-functionally with medical, project management, quality, and data management teams, and support sites during audits and inspections
Qualifications
Degree in a scientific or medical discipline, or relevant vocational training in healthcare
Several years of experience as a Clinical Research Associate, with solid hands-on experience in Phase II and III clinical trials
Oncology experience is highly preferred
Strong knowledge of GCP, ICH guidelines, and clinical research processes, with high attention to detail in managing study data and regulatory requirements
Fluent German and English, both written and spoken, with willingness to travel nationally and internationally
What We Offer
A Bit More About Us
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