Clinical Research Associate, Sponsor Dedicated, IVD

Position Summary

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

• 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
• Obtaining opinions and input regarding investigational products from laboratories or customers, who may be considered key opinion leaders

The CRA is responsible for maintaining and continuously improving the quality system and achieving quality objectives through daily actions.

Job Function/Responsibilities

• Performing or coordinating aspects of 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 other cross functional 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, and client policies and procedures

Experience, Skills and Knowledge 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, 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

Education Requirements

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