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Clinical Research Associate
TFS HealthScience - Contract Research Organization. Initiate, monitor, and close out study sites during study conduct .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in monitoring clinical trials, ensuring compliance with GCP, ICH guidelines, and regulatory requirements while maintaining subject safety and data integrity. Proficient in preparing monitoring reports and managing site documentation within clinical research environments.
Highest-signal resume keywords
Clinical Trial MonitoringGood Clinical Practice (GCP)ICH GuidelinesSite Documentation ManagementBachelor's Degree in Life Sciences
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Research ExperienceProtocol Compliance VerificationData Integrity AssuranceMonitoring Visit Report PreparationElectronic CRF Review
Soft Skills
Strong Written CommunicationStrong Verbal CommunicationExcellent Organizational SkillsAbility to Work IndependentlyTeam Collaboration
Tools & Technologies
CTMSETMFISF
Industry Keywords
Clinical TrialsSubject SafetyRegulatory RequirementsInformed Consent ProceduresInvestigational Product Management
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- Competitive compensation package
- Comprehensive benefits
- Opportunity for personal and professional growth
- Collaborative and innovative work environment