Job Description

Clinical Research Associate Opportunity

Are you a highly motivated Clinical Research Associate looking to make a significant impact in a growing medical device company? Our start-up client is seeking a driven CRA 2 to join their Clinical Operations team and play a pivotal role in post-FDA-approval data collection for their innovative product. This is an exciting opportunity to contribute to a groundbreaking device that helps critically ill patients on mechanical ventilators breathe more effectively.

Your role with the company:

As a CRA, you will be instrumental in ensuring the successful execution of post-market clinical studies. Your responsibilities will include:

• Site Management: Oversee 8-20 clinical sites across the U.S., ensuring high-quality site management, data integrity, and regulatory compliance.
• Documentation & Training: Create and review clinical documentation, develop comprehensive training plans for site personnel, and verify adherence to protocols and regulations.
• Site Communication & Support: Act as a primary point of contact for sites, answering questions, guiding them through the qualification process, and collaborating with physicians.
• Contract Negotiation: Assist with the negotiation of contracts with clinical sites.
• Travel: Travel 3-4 times per month during the study startup phase, reducing to an average of 1-2 times per month thereafter, to activate sites and conduct on-site monitoring.
• Regulatory Compliance: Maintain the electronic Trial Master File (TMF), ensure investigational device accountability, and support quality teams during external audits.
• Data Oversight: Review and ensure timely reporting of adverse events, concomitant medications, and other protocol-required data, supporting query resolution and reviewing Data Clarification Forms (DCFs).
• Team Collaboration: Participate in cross-functional team meetings, prepare meeting agendas and minutes, and share best practices to contribute to continuous improvement initiatives within Clinical Operations.

Desired Profile:

• A Bachelor's degree (science or healthcare discipline preferred).
• 1+ years of dedicated clinical monitoring (on-site) experience at a medical device company.
• 5+ years of experience as a clinical research coordinator.
• Strong understanding of ISO, GCP, ICH, FDA, and other applicable clinical research regulations.
• Experience with IDE studies and involvement in startup phases.
• A detail-oriented, proactive approach with proven effectiveness in managing multiple priorities.
• Ability to travel up to 50% and close proximity to a major airport.

Preferred Qualifications:

• Experience in an ICU environment.
• Prior involvement with site monitoring and close-out activities.
• Familiarity with risk-based monitoring tools or eTMF systems.
• Experience mentoring junior staff.

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