CareDx, Inc.
Biotech
Sr.ClinicalResearchAssociate
“Sr. Clinical Research Associate at CareDx, Inc.. Skills: Clinical research, Site management, Data integrity. Conduct site visits. Oversee site visits”
Industry & Context.
Analytical skills
Travel up to 75%
What They're Looking For.
Must Have
Bachelor’s degree or higher, 5+ years of experience, Knowledge of GCP, Knowledge of FDA regulations, Knowledge of ISO standards, Proficiency in EDC systems, Proficiency in CTMS, Proficiency in Microsoft Office Suite, Excellent understanding of medical terminology, Excellent understanding of clinical trial processes, Proven ability to manage multiple studies, Proven ability to manage priorities, Demonstrated ability to work independently, Demonstrated ability to work collaboratively, Ability to adapt quickly
Nice to Have
Certification (CCRC or CCRA) is a plus
What You'll Do.
Ensure protocol adherence
Ensure patient safety
Collaborate with Principal Investigators
Collaborate with study coordinators
Collaborate with cross-functional teams
Ensure compliance with ICH/GCP
Ensure compliance with IRB requirements
Ensure compliance with internal monitoring plans
Identify data collection issues
Resolve data collection issues
Review data discrepancies
Reconcile data queries
Reconcile data listings
Reconcile data discrepancies
Maintain study documentation
Lead study team meetings
Contribute to protocol development
Contribute to protocol amendments
Support site recruitment
Provide oversight for enrollment goals
Provide technical expertise
Assist in SOP development
Assist in workflow development
Assist in template development
Partner to manage timelines
Partner to manage budgets
Partner to manage resources
Liaise with regulatory authorities
Ensure timely execution of monitoring reports
Ensure compliant execution of monitoring reports
Ensure timely execution of trip reports
Ensure compliant execution of trip reports
Ensure timely execution of follow-up letters
Ensure compliant execution of follow-up letters
Monitor site performance metrics
Facilitate stakeholder communication
How You'll Work.
Team & Collaboration
Cross-functional teams; Remote teams
Communication Scope
Interpersonal skills
Process & Methodology
Timeline management, Budget management, Resource management
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