Clinical Research Associate

The Clinical Research Associate (CRA) will design, plan, coordinate and conduct activities for initiating, monitoring and completing clinical research studies for in vitro diagnostics.

Responsibilities include:

• Ensuring studies are conducted and documented according to the study protocol, standard operating procedures, good clinical practices and regulatory requirements
• Validating product performance claims
• Supplying data for critical Regulatory submissions
• Defining the functional and clinical utility of investigational products
• Obtaining opinions and input from laboratories or customers who are key opinion leaders

The CRA will also perform or coordinate aspects of clinical studies, including site selection, study initiation, site monitoring and study closeout.

Requirements:

• ≥2 years of experience as a Clinical Research Associate, with specific in vitro diagnostics study experience
• CRA certification by recognized professional organization is a plus
• Excellent oral and written communication skills
• Excellent planning, organizing, interpersonal and leadership skills
• Ability to work independently and make sound decisions
• Demonstrated experience in computer skills, including Microsoft Word, Excel and basic templates

Education Requirements:

• Minimum - Bachelor's degree in science or relevant field
• Medical technology degree preferred

The potential base pay range for this role is $90,200.00 - $197,500.00.