Clinical Research Associate, Sponsor Dedicated, IVD

$87,200 - $189,000/Yr

Quintiles - Carlsbad, CA

Part-time - Mid Level

Carlsbad, CA

Ambulatory Health Care Services

About the position

The Clinical Research Associate (CRA) is responsible for designing, planning, coordinating, and conducting clinical research studies for in vitro diagnostics. This role involves ensuring compliance with study protocols, regulatory requirements, and good clinical practices while validating product performance claims and supporting regulatory submissions. The CRA plays a crucial role in maintaining and improving the quality system and achieving quality objectives through daily actions.

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 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, and helping to develop standard operating procedures to ensure studies adhere to FDA regulations, Good Clinical Practices, IVD directives, and client policies.

Requirements

• ≥2 years of experience as a Clinical Research Associate, with specific in vitro diagnostics study experience.
• CRA certification by a 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 including Microsoft Word, Excel, and basic templates.

Nice-to-haves

• Medical technology degree preferred, but not required if R&D background is adequate.

Benefits

• Health and welfare benefits including health insurance, paid time off, and retirement plans.