Job Description

Senior Clinical Research Associate (Sr. CRA)

As a Senior Clinical Research Associate (Sr. CRA) , you will manage and monitor clinical studies across U.S. and international sites, ensuring compliance with FDA, ICH-GCP, and regulatory guidelines. This role requires strong organizational skills, attention to detail, and the ability to work independently while supporting multiple studies.

Key Responsibilities:

• Provide case support and oversight of study activities.
• Develop and manage clinical documents, including informed consent forms and study guides.
• Monitor study sites, review case report forms, and ensure protocol adherence.
• Prepare study monitoring tools, reports, and regulatory documentation.
• Support IRB/IEC submissions and regulatory compliance.
• Track and resolve study queries, protocol deviations, and adverse events.
• Coach and mentor CRAs while ensuring adherence to study timelines.
• Participate in site audits and ensure proper investigational product accountability.

Qualifications:

• BS/BA degree or equivalent experience.
• 5+ years in clinical research, with at least 3 years as a CRA in device or biotech trials.
• Cardiovascular device experience preferred.
• CRA certification (CCRA, CCRP) strongly preferred.
• Proficient in EDC, CTMS, Microsoft Office, and Smartsheet.
• Strong knowledge of FDA and international regulatory requirements.
• Excellent communication, critical thinking, and organizational skills.
• Ability to travel 30%-50%, including overnight and international travel.

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