Clinical Research Associate, Sponsor Dedicated
Location: Durham, North Carolina; Overland Park, Kansas; Parsippany, New Jersey; San Diego, California
When you join IQVIA as a sponsor-dedicated CRA, you’ll enjoy the stability and resources of a leading, global contract research organization while gaining direct experience with one of our customers. Whether you're just starting out or looking to deepen your expertise, this role promises to offer intentional career growth and professional development.
With access to world-class training and mentoring, you’ll have the opportunity to put your passions to work in an environment designed to help you gain experience in a wide variety of therapeutic areas.
- Full Time
- Level: Entry-level, Mid-level, Senior-level
- Travel: Yes
What makes sponsor-dedicated CRAs at IQVIA successful? Check out the top traits we’re looking for and see if you have the right mix.
As you grow your CRA career at IQVIA, you’ll play an important role in helping our customers drive healthcare forward and impact the lives of patients around the world.
IQVIA offers a robust development plan for CRAs, including trainings, mentorship programs, and cross-functional career meetings. These conditions made me feel ready, confident and well-trained to execute the role of a CRA with quality and integrity.Alberto, Clinical Research Associate 2
IQVIA places real emphasis on the training and development of employees. This is invaluable for someone starting out or looking to progress their career in clinical research. I find it extremely rewarding to work for a company that strives to grow and retain its talent and equips you with the skills and experience needed to succeed in your career.Oliver, Clinical Research Associate 1
Resources that promote your career growth
Leaders that support flexible work schedules
Clear pathways to success
Teams that work together to achieve common goals
Dynamic work environments that expose you to new experiences
Programs to help you build knowledge and gain skills
Clinical Research Associate, Sponsor Dedicated
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.
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