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Senior Clinical Research Associate
TFS HealthScience - Contract Research OrganizationSenior Clinical Research Associate for TFS HealthScience ensuring ophthalmology study success. Balancing remote and site-based responsibilities with a focus on quality and compliance.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- 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
What you’ll need- Degree in a scientific or medical discipline, or completed vocational training in a relevant healthcare or medical field
- Strong knowledge of GCP, ICH guidelines, and clinical research processes, with a high level of accuracy in handling study data and regulatory requirements
- Minimum 5 years experience working as a CRA and 1 year experience in Ophthalmology
Benefits
Comp & perks- Competitive compensation package
- Comprehensive benefits
- Opportunity for personal and professional growth
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
eCRF data reviewprotocol deviation reportingstudy documentation maintenancemonitoring plan executionstudy site performance oversightregulatory complianceclinical research processesdata managementauditing supportinspection readiness
Soft Skills
communicationcollaborationproblem-solvingorganizational skillsattention to detail
Certifications
GCP certification