Clinical Research Associate, Sponsor Dedicated, IVD

IQVIA

. Design, plan, coordinate, and conduct activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics .

Posted 11/9/2026full-timeUnited StatesJuniorMid-Level💰 $90,200 - $197,500 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical research study design and execution, ensuring compliance with regulatory requirements and good clinical practices. Proficient in coordinating activities related to in vitro diagnostics and maintaining quality systems.

Highest-signal resume keywords

Clinical Research Associate ExperienceIn Vitro Diagnostics Study ExperienceCRA CertificationRegulatory Compliance KnowledgeExcellent Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study DesignData ValidationStudy Protocol AdherenceQuality System MaintenanceSite MonitoringProblem SolvingRegulatory Submission PreparationFunctional Utility DefinitionInvestigational Product EvaluationStudy Closeout Activities

Soft Skills

Leadership SkillsInterpersonal SkillsPlanning SkillsOrganizational SkillsIndependent Decision Making

Tools & Technologies

Microsoft WordMicrosoft ExcelClinical Research Software

Certifications & Qualifications

CRA Certification

Industry Keywords

Good Clinical PracticesFDA RegulationsIVD DirectivesClinical ResearchMedical Technology

About the role

Key responsibilities & impact

Design, plan, coordinate, and conduct activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics
Ensure studies are conducted and documented according to study protocols, standard operating procedures, good clinical practices, and applicable regulatory requirements
Validate product performance claims
Supply data for critical regulatory submissions
Define the functional and clinical utility of investigational products
Obtain opinions and input regarding investigational products from laboratories or customers, including key opinion leaders
Maintain and continuously improve the quality system and achieve quality objectives through daily actions
Perform or coordinate clinical study activities, including site selection, study initiation, site monitoring, and study closeout
Maintain communication with study investigators to ensure timely completion and achievement of study objectives
Interface with cross-functional staff to support post-launch activities
Review cases with investigators to resolve discrepancies
Understand and implement federal regulations and help develop standard operating procedures to ensure adherence to FDA regulations, Good Clinical Practices, IVD directives, and client policies and procedures

Requirements

What you’ll need

≥2 years of experience as a Clinical Research Associate
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 analyze and solve problems
Demonstrated computer skills, including 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

Benefits

Comp & perks

Health and welfare benefits
Other benefits
Potential incentive plans, bonuses, and/or other forms of compensation