IVD CRA - 177506

Responsibilities: of the IVD CRA: • Conduct site qualification, initiation, monitoring, and closeout visits for IVD clinical studies. • Ensure clinical trial sites comply with study protocols, Good Clinical Practice (GCP), and applicable regulatory requirements. • Review site documentation, source data, and case report forms to ensure data accuracy and completeness. • Identify, document, and follow up on protocol deviations and corrective action plans. • Collaborate with investigators, study coordinators, clinical teams, and sponsors to support study objectives. • Monitor patient enrollment, retention, and study progress across assigned sites. • Prepare monitoring visit reports and maintain accurate trial documentation. • Support audit and inspection readiness activities throughout the clinical study lifecycle. Requirements of the IVD CRA: • Bachelor's degree in Life Sciences, Clinical Research, Biology, Nursing, or a related field. • 3+ years of Clinical Research Associate experience supporting IVD, diagnostic, medical device, or biotechnology studies. • Strong knowledge of FDA regulations, ICH-GCP guidelines, and clinical trial processes. • Experience performing onsite and remote monitoring activities. • Excellent communication, documentation, and relationship management skills. • Ability to travel as needed to support clinical study sites. • Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS) preferred. • Strong organizational skills with the ability to manage multiple studies simultaneously. Compensation: for the IVD CRA: • Salary range: $110,000 - $140,000 • Full Comprehensive Benefits: Health, Vision, Dental, PTO, Paid Holiday and Sick Leave if Required by Law.