Clinical Research Associate II - MedTech
Core
Perform site monitoring and management to ensure clinical studies for medical devices and diagnostics are conducted per protocol and regulations.
Role type
Clinical Research Associate (MedTech)
Builds
Clinical trial data and regulatory compliance for medical device and diagnostic clients
Domain
Medical device and diagnostics industry
Required skills
GCP and ICH guidelines knowledge, site monitoring, subject recruitment tracking, protocol administration, TMF/ISF management, data query resolution, financial management
Preferred skills
Therapeutic knowledge, laptop and mobile device proficiency
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 phases, manage site financials
Seniority
Mid-level, hands-on IC