Clinical Research Associate, Sponsor Dedicated, IVD

$87,200 - $189,000/Yr

IQVIA - Parsippany-Troy Hills, NJ

Part-time - Mid Level

Parsippany-Troy Hills, NJ

Professional, Scientific, and Technical Services

About the position

The Clinical Research Associate (CRA) will oversee the design, planning, coordination, and execution of clinical research studies specifically for in vitro diagnostics. This role is crucial in ensuring compliance with regulatory standards and the successful completion of studies, while also maintaining the quality system and achieving quality objectives.

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

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

Nice-to-haves

• CRA certification by recognized professional organization

Benefits

• Health insurance
• Incentive plans
• Bonuses
• 401k options
• Paid time off