Clinical Research Associate II - MedTech
Core
Perform site monitoring and management to ensure clinical studies are conducted per protocol and regulations for medical device and diagnostics clients.
Role type
Clinical Research Associate (MedTech)
Builds
Clinical trial data and regulatory compliance for medical device and diagnostics sponsors
Domain
Medical device and diagnostics clinical research
Required skills
GCP and ICH guidelines knowledge, site monitoring, subject recruitment management, protocol administration, regulatory submission tracking, TMF/ISF management, documentation creation, financial management
Preferred skills
Bachelor's degree in scientific discipline or healthcare, therapeutic knowledge, computer proficiency (Word, Excel, PowerPoint, mobile devices)
Technologies
Microsoft Word, Excel, PowerPoint, laptop, iPhone, iPad
Responsibilities
Conduct site monitoring visits (selection, initiation, monitoring, close-out), drive subject recruitment plans, administer protocol training, evaluate site quality and adherence, track regulatory submissions and enrollment, maintain Trial Master File and Investigator's Site File, generate visit reports and action plans, support start-up phase, manage site financials and invoices
Seniority
Mid-level, hands-on IC