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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Clinical Trial Processes, including site management, data processing, and compliance with SOP, ICH-GCP, and protocol standards. Proficient in analyzing clinical data trends and communicating effectively with stakeholders in both English and Spanish.
Highest-signal resume keywords
Senior CRA ExperienceClinical Operations LeadershipClinical Trial Process UnderstandingData Quality AssessmentBilingual Communication
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Site ManagementData ProcessingData CleaningTrend AnalysisIssue Identification
Soft Skills
Collaborative WorkProactive Problem SolvingTrust Building
Tools & Technologies
Dashboards
Industry Keywords
SOP ComplianceICH-GCPClinical OperationsClinical ManagementVirtual Team Collaboration
About the role
Key responsibilities & impact- Review site qualification, initiation, monitoring and close-out visit reports for quality, completeness, SOP, ICH-GCP and protocol compliance
- Capture report information in dashboards and analyze issues, categories, issue age and recurring trends for the Clinical Operations Leader team
- Identify potential data quality or compliance concerns, assess impact on study timelines, and escalate critical issues with recommended solutions
- Communicate study-specific trends and issues to Clinical Operations Leaders and support regular trend reporting
- Escalate CRA report-quality or documentation concerns through appropriate line-management channels
- Work under the guidance of an experienced Clinical Operations Leader or Line Manager
- May have sponsor-facing responsibilities
Requirements
What you’ll need- Strong command of written and spoken English and Spanish required
- Minimum of five years of Senior CRA experience required
- Relevant Clinical Operations Leader or project-lead experience will also be considered
- Strong understanding of the clinical trial process, cross-functional clinical activities, site management, data processing and data cleaning
- Degree in a life science, nursing qualification, or relevant clinical and/or clinical management experience
- Ability to work collaboratively across virtual teams
- Proactive issue identification and prioritization of competing needs
- Ability to build trust with internal and external stakeholders
Benefits
Comp & perks- Professional growth and development opportunities
- Work-life balance
- Flexible working hours
- Fully home-based work in Mexico or Colombia
- Very occasional travel for monitoring support may be required