Clinical Research Associate, Sponsor Dedicated, IVD

$87,200 - $189,000/Yr

IQVIA - Overland Park, KS

Part-time - Mid Level

Overland Park, KS

5,001-10,000 employees

Professional, Scientific, and Technical Services

About the position

The Clinical Research Associate (CRA) is responsible for overseeing and conducting clinical research studies specifically for in vitro diagnostics. This role involves ensuring compliance with study protocols, regulatory requirements, and good clinical practices while maintaining the quality of the research process. The CRA will also engage with key opinion leaders and support the development of investigational products through various stages of clinical trials.

Responsibilities

• Designing, planning, coordinating, and conducting clinical research studies for in vitro diagnostics.
• Ensuring studies are conducted in accordance with protocols, standard operating procedures, and regulatory requirements.
• Validating product performance claims and supplying data for regulatory submissions.
• Defining the functional and clinical utility of investigational products.
• Maintaining communication with study investigators to ensure timely completion of studies.
• Interfacing with cross-functional staff to support post-launch activities.
• Reviewing cases with investigators to resolve discrepancies.
• Understanding and implementing federal regulations and developing standard operating procedures.

Requirements

• Minimum of 2 years of experience as a Clinical Research Associate, specifically in in vitro diagnostics studies.
• Bachelor's degree in science or a relevant field.
• Excellent oral and written communication skills.
• Strong planning, organizing, interpersonal, and leadership skills.
• Ability to work independently and make sound decisions.
• Demonstrated computer skills, including proficiency in Microsoft Word and Excel.

Nice-to-haves

• CRA certification by a recognized professional organization is a plus.
• Medical technology degree preferred, but not required if R&D background is adequate.

Benefits

• Competitive salary range of $87,200.00 - $189,000.00 based on qualifications and experience.
• Incentive plans, bonuses, and other forms of compensation may be offered.
• Health and welfare benefits.