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. Responsibilities include but are not limited to:

• 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, and
• 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

#CRASDAJD

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $90,200.00 - $197,500.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.