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Piper Companies is seeking a Clinical Research Associate (CRA) for a contract position supporting a global leader in the medical device industry specializing in cardiology devices. The Senior Clinical Research Associate (CRA) will oversee clinical trial monitoring and compliance activities for cardiovascular studies in Honolulu, HI.
Job Responsibility:
Conduct site monitoring visits to ensure compliance with GCP, ICH, and regulatory guidelines
Provide protocol training and maintain effective communication with study sites
Assess site adherence to protocol and regulatory requirements, reporting any quality issues
Support subject recruitment and adapt recruitment plans as needed
Track study progress, including regulatory approvals, enrollment, and data collection
Requirements:
Minimum of 2 years of onsite monitoring experience in medical device or cardiology trials
Strong knowledge of GCP, ICH guidelines, and FDA regulations
Proficiency in CTMS, EDC systems, and Microsoft Office Suite
Excellent organizational and communication skills with experience in site management
Bachelor’s degree in life sciences, nursing, or a related field (advanced degree preferred)