Senior Clinical Research Associate executing clinical studies for TFS HealthScience, collaborating across teams and managing site performance responsibilities.
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 applicable monitoring plan
Oversee study site performance, including recruitment progress, and provide ongoing support to sites on study-related questions and operational issues
Review eCRF data, timelines, and queries; identify and report protocol deviations; and maintain clear communication with project management and sponsors
Review and maintain 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 management, and data management teams, and support sites during audits and inspections
Requirements
Degree in a scientific or medical discipline, or completed vocational training in a relevant healthcare or medical field
Additional training in clinical research or CRA certification, combined with several years of experience as a Clinical Research Associate
Strong knowledge of GCP, ICH guidelines, and clinical research processes, with a high level of accuracy in handling study data and regulatory requirements
Fluent German and English language skills, both written and spoken, with willingness to travel nationally and internationally as required
Benefits
Opportunities for personal and professional growth in a rewarding environment
Team that values collaboration, quality, and making a difference in the lives of patients
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