Senior Clinical Research Associate
TFS HealthScience - Contract Research Organization
full-time
Posted on:
Location Type: Hybrid
Location: Frankfurt • Germany
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Job Level
Tech Stack
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical researcheCRF data reviewprotocol deviation reportingstudy documentation maintenancemonitoring plan executiondata managementstudy site performance oversightrecruitment progress trackinginspection readinessregulatory compliance
Soft Skills
communicationcollaborationproblem-solvingorganizational skillsattention to detailindependencesupportivenessadaptabilityaccuracywillingness to travel
Certifications
CRA certificationGCP trainingICH guidelines training