Lead Research Specialist performing complex laboratory tests and procedures in Emory University's School of Medicine. Contributing to innovative research and protocol design under minimal supervision.
TO
Hybrid Clinical Research Associate – CRA
Posted 5 days ago
About the role
- Clinical Research Associate ensuring high‑quality clinical trial execution across all study phases. Supporting patient safety and protocol compliance while collaborating with investigative sites.
Responsibilities
- Manage site start-up, initiation, monitoring (remote and onsite), and close-out activities
- Ensure protocol, GCP, and regulatory compliance at site level
- Perform SDV/SDR, CRF review, and data quality oversight according to the monitoring plan
- Support investigators and site staff through training and ongoing guidance
- Drive site performance, proactively identifying and resolving issues
- Ensure timely reporting of SAEs and follow-up documentation
- Maintain inspection readiness, including ISF and essential documents
- Ensure accurate and timely updates to CTMS and eTMF
- Collaborate with data management, patient safety, and other stakeholders
- Support audits and regulatory inspections as required
Requirements
- Bachelor’s degree in life sciences or a related field
- Strong knowledge of ICH-GCP and applicable local regulations
- Solid understanding of clinical trial processes, monitoring, and data management
- Experience with risk-based monitoring and remote monitoring approaches
- Willingness to travel as required
- Fluency in English and German
Benefits
- We provide a competitive compensation package
- comprehensive benefits
- opportunity for personal and professional growth in a rewarding environment
- collaboration, innovation, and making a difference in the lives of patients
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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