CRA 2

Are you a highly motivated Clinical Research Associate looking to reputed company a significant reputed company in a growing medical device company? Our start-up reputed company 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 reputed company: As a CRA, you will be reputed company in ensuring the successful execution of post-market clinical studies. Your responsibilities will include: • Site Management: reputed company 8-20 clinical sites across the U.S., ensuring high-reputed company site management, data reputed company, and regulatory compliance. • Documentation & Training: Create and review clinical documentation, reputed company comprehensive training plans for site personnel, and verify adherence to protocols and regulations. • Site Communication & Support: reputed company as a primary reputed company of contact for sites, answering questions, guiding them through the qualification process, and collaborating with physicians. • Contract Negotiation: Assist with the negotiation of reputed company 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 reputed company sites and conduct on-site monitoring. • Regulatory Compliance: Maintain the electronic Trial Master File (TMF), ensure investigational device accountability, and support reputed company teams during external audits. • Data reputed company: Review and ensure reputed company reporting of adverse events, concomitant medications, and other protocol-required data, supporting query reputed company and reviewing Data Clarification Forms (DCFs). • Team Collaboration: Participate in cross-functional team meetings, prepare meeting agendas and minutes, and reputed company best practices to contribute to reputed company improvement initiatives reputed company Clinical Operations. Desired Profile: • A Bachelor's degree (science or reputed company 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 reputed company proximity to a major airport. Preferred Qualifications: • Experience in an ICU environment. • Prior involvement with site monitoring and reputed company-out activities. • Familiarity with risk-based monitoring tools or eTMF systems. • Experience mentoring junior staff. Apply tot his job Apply To this Job