CV BANK- CRA I- Med Techs

Icon - Remote, OR

Full-time - Mid Level

Remote, OR

Professional, Scientific, and Technical Services

About the position

The Medical Technologist position at ICON is designed for individuals interested in transitioning to a Clinical Research Associate (CRA) I role. This position involves leading the design, planning, coordination, and execution of clinical research studies specifically for in vitro diagnostics. The CRA will ensure compliance with regulatory requirements and good clinical practices while validating product performance and gathering critical data for regulatory submissions.

Responsibilities

• 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
• 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

Requirements

• 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

Nice-to-haves

• CRA certification by recognized professional organization
• Supervision experience or experience in a leadership role

Benefits

• Comprehensive and competitive total reward package
• Excellent level of base pay
• Wide range of variable pay and recognition programs
• Best in class employee benefits
• Supportive policies and wellbeing initiatives
• Continuous learning culture
• Professional development opportunities