CRA II, Post-Market Medical Device Trials

Custom Search Inc.; Minneapolis (MN); In loco; USD 70.000 - 95.000; Tempo pieno

Descrizione del lavoro

Custom Search Inc. is seeking a Clinical Research Associate II to advance post-FDA approval data collection for a medical device product. You will oversee site management, data integrity, and regulatory compliance across 8-20 U.S. sites, with regular travel.

The role emphasizes collaboration, training plan development, contract support, and support during external audits. A science/healthcare background and hands-on CRA experience are required.

Competenze

• Bachelor's degree in science or healthcare (preferred).
• 1+ years of on-site clinical monitoring experience at a medical device company.
• 5+ years as a clinical research coordinator.
• Strong knowledge of ISO, GCP, ICH, FDA regulations.
• Experience with IDE studies and startup phases.
• Detail-oriented with ability to manage multiple priorities.
• Willingness to travel up to 50% and proximity to a major airport.

Mansioni

• Oversee 8-20 clinical sites across the U.S., ensuring data integrity and regulatory compliance.
• Create and review clinical documentation; develop training plans for site personnel.
• Serve as primary contact for sites; guide qualification process and physician collaboration.
• Assist with contract negotiations with clinical sites.
• Travel 3-4 times per month in startup phase; 1-2 times per month thereafter to activate sites.
• Maintain TMF, ensure investigational device accountability, support external audits.
• Review adverse events and protocol data; assist with queries and DCF reviews.
• Participate in cross-functional meetings; prepare agendas and minutes; share best practices.

Conoscenze

Detail-oriented

Multitasking

Travel readiness

Team collaboration

Formazione

Bachelor's degree

Strumenti

eTMF systems

Risk-based monitoring tools

IDE studies

Descrizione del lavoro

Custom Search Inc. is seeking a Clinical Research Associate II to advance post-FDA approval data collection for a medical device product. You will oversee site management, data integrity, and regulatory compliance across 8-20 U.S. sites, with regular travel.

The role emphasizes collaboration, training plan development, contract support, and support during external audits. A science/healthcare background and hands-on CRA experience are required.