Clinical Research Associate
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Job Description
Clinical Research Associate monitoring ophthalmology clinical trials for global CRO TFS HealthScience. Ensuring site compliance, participant safety, data integrity, and accurate study documentation.
Responsibilities:
- Initiate, monitor, and close out study sites during study conduct
- Monitor clinical trials on-site and remotely according to SOPs, GCP, ICH guidelines, sponsor requirements, and applicable regulations
- Perform monitoring activities to ensure subject safety, data integrity, and quality
- Verify informed consent procedures and protocol compliance
- Review electronic or paper CRFs and subject source documentation for validity, completeness, and accuracy
- Verify management and accountability of Investigational Product
- Prepare monitoring visit reports, document findings and follow-up actions, update tracking systems, and escalate issues
- Maintain site documentation and support eTMF and ISF compliance
- Update CTMS and other project systems with accurate site information
Requirements:
- Bachelor's Degree, preferably in Life Sciences, Nursing, or equivalent
- Minimum 1 year of relevant clinical research experience or relevant academic background related to clinical trials or clinical development activities
- Understanding of Good Clinical Practice (GCP), ICH guidelines, and applicable regulatory requirements
- Strong written and verbal communication skills with fluency in English
- Excellent organizational skills
- Ability to work independently and within a matrix team environment
Benefits:
- Competitive compensation package
- Comprehensive benefits
- Opportunity for personal and professional growth
- Collaborative and innovative work environment
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