IQVIA Clinical Research Associate, Sponsor Dedicated in Overland Park, Kansas
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.
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 Roche 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
Understanding of basic Statistical principals
- Minimum - Bachelor's degree in science or relevant field.
Medical technology degree preferred, but not required if R&D background is adequate
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com .
IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled
IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at email@example.com to arrange for such an accommodation.
At IQVIA, we have a vision. Where every healthcare decision is based on evidence. Where data science and human science come together to improve global health. Where new and creative solutions aren’t just possible – they are expected.
Thank you for your interest in growing your career with us. It takes insight, curiosity, and intellectual courage to transform healthcare. The 56,000+ employees of the IQVIA family of companies, including Q2 Solutions, are reimagining a world without the consequences of disease. We are brave minds bringing powerful ideas to reality. At IQVIA, you can truly make an impact in an environment where you’re supported to succeed.