Senior CRA - In-Vitro Diagnostics

ICON is looking for a Senior CRA with IVD (in vitro diagnostics) experience!

Responsibilities:

The Clinical Research Associate (CRA) will lead in designing, planning, coordinating, and conducting all activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics. Responsibilities include:

• Ensuring studies are conducted and documented in accordance with the study protocol, standard operating procedures, good clinical practices and other applicable regulatory requirements; • Validating product performance claims; • Supplying data for critical Regulatory submissions; • Defining the functional and clinical utility of investigational products, and • Obtaining opinions and input regarding investigational products from laboratories or customers, who may be considered key opinion leaders.

• Performing or coordinating aspects of external clinical studies including site selection, study initiation, site monitoring, and study closeout. • Maintaining communication with study investigators to ensure studies are completed in a timely fashion and ensuring that study objectives are met. • Interfacing with staff to support post launch activities. • Reviewing cases with investigators to resolve discrepancies. • Understanding and implementing federal regulations, helping to develop standard operating procedures in order to ensure that studies adhere to FDA regulations, Good Clinical Practices, IVD directives, policies and procedures.

Qualifications:

5 years of experience as a Clinical Research Associate, with specific in vitro diagnostics study experience preferred

• CRA certification by recognized professional organization is a plus, but not mandatory • Excellent oral and written communication skills • Excellent planning, organizing, interpersonal and leadership skills • Ability to work independently to make sound decisions and to analyze and solve problems • Demonstrated experience in computer skills to include Microsoft Word, Excel, and basic templates • Statistical knowledge • Supervision experience or experience in a leadership role preferred

Minimum - Bachelor's degree in relevant field. Medical technology degree preferred, but not required if R&D background is adequate