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Piper Companies

Clinical Research Associate

Piper Companies, Honolulu, Hawaii, United States, 96814

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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 .

Responsibilities

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.

Qualifications

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).

Compensation

Salary Range: $145,000 - $165,000/year (USD)

Application Details

Job opens for applications on 01/09/26. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords: clinical research, clinical trials, GCP, regulatory compliance, clinical monitoring, cardiology devices, site management, protocol adherence, patient recruitment, adverse event reporting, clinical study, documentation, IRB submissions, clinical trial management, data analysis, quality assurance, clinical operations, SOP, FDA regulations, ICH guidelines, electronic data capture, cardiovascular trials, risk management, stakeholder management, project management, communication skills, collaboration, medical device, clinical data management, regulatory submissions, clinical research ethics, clinical study reports, budgeting, contract negotiation, time management, decision making, clinical trial protocols.

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