CLINICAL RESEARCH ASSOCIATE, SPONSOR DEDICATED, IVD

Company: IQVIA
Location: Carlsbad
Posted on: October 30, 2024

Job Description:

Position SummaryThe 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, andObtaining 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/ResponsibilitiesPerforming 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 experienceCRA certification by recognized professional organization is a plus, but not mandatoryExcellent oral and written communication skillsExcellent planning, organizing, interpersonal and leadership skillsAbility to work independently to make sound decisions and to analyze and solve problemsDemonstrated experience in computer skills to include Microsoft Word, Excel, and basic templatesEducation RequirementsMinimum - Bachelor's degree in science or relevant field.Medical technology degree preferred, but not required if R&D background is adequate#CRASDAJDIQVIA 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.comWe are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoeIQVIA's ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-statusThe potential base pay range for this role, when annualized, is $87,200.00 - $189,000.00. 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.IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare - and human health - forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.EEO Minorities/Females/Protected Veterans/Disabled

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