Study Start-Up Clinical Research Associate (Sponsor-Dedicated) | IQVIA | Overland Park, Kansas
Location: Overland Park, Kansas
Work Model: Field-Based
Job Type: Full-Time
Job ID: R1513886
Additional Locations: Open to candidates anywhere in the United States
Travel Requirement: 70–80%
IQVIA is hiring an experienced Study Start-Up Clinical Research Associate (SSU CRA) to support sponsor-dedicated clinical research operations across multiple therapeutic areas. This position plays a critical role in site identification, feasibility, initiation, and early study execution for Phase I–IV clinical trials.
Position Overview
The Study Start-Up CRA is responsible for all study-specific start-up deliverables, from country allocation to site greenlight. This includes managing regulatory submissions, coordinating site preparation, and ensuring compliance with ICH-GCP, local regulations, and sponsor SOPs. The role requires proactive communication, efficient documentation management, and close collaboration with cross-functional SSU teams.
Applicants must have:
• Experience in Study Start-Up activities
• Minimum 8 months of on-site clinical monitoring experience
Key Responsibilities
Study Start-Up and Site Management
Lead site selection activities and assess site feasibility for assigned clinical studies.
Serve as the primary point of contact for sites during site selection, start-up, and regulatory submission processes.
Ensure all study milestones, KPIs, and timelines are achieved as per country commitments.
Prepare, collect, and verify site-specific regulatory documents including CVs, GCP certificates, financial disclosures, and delegation logs.
Coordinate IRB/IEC and Health Authority submission packages and support document preparation.
Prepare and finalize site-specific documents such as informed consent forms and patient-facing materials.
Regulatory, Documentation, and Compliance
Ensure TMF and ISF documentation is complete, accurate, and inspection-ready.
Support audits, inspections, and resolution of regulatory deficiencies.
Maintain up-to-date information in clinical trial systems until site greenlight.
Ensure adherence to ICH-GCP, local regulatory guidelines, sponsor procedures, and financial compliance standards.
Cross-Functional Collaboration
Work closely with Study Start-Up Team Leads, SSU Managers, Feasibility Managers, and Site Partnership Managers.
Collaborate with global study teams to ensure alignment with overall study timelines.
Assist with vendor setup activities and investigator compensation agreements.
Support the development and execution of country-level SSU strategies.
Required Qualifications and Experience
Bachelor’s degree in a life science, healthcare, or related field (required).
At least 8 months of on-site clinical monitoring experience (required).
Hands-on experience with Study Start-Up processes (required).
Strong understanding of ICH-GCP, clinical regulatory requirements, and study start-up documentation.
Excellent communication and organizational skills.
Ability to manage multiple priorities and travel extensively across assigned regions.
Proficiency with clinical trial management systems and standard productivity software.
Equivalent combinations of education, training, and experience may be considered.
Key Competencies
Strong analytical and documentation skills.
Ability to establish effective relationships with investigators and site staff.
Proactive problem-solving and risk identification.
Commitment to high-quality deliverables and strict regulatory compliance.
Capacity to work independently while supporting cross-functional operations.
Compensation
Annual Base Pay Range:
USD 71,900 – 145,300
Actual compensation varies depending on experience, qualifications, work location, and schedule. Additional incentives, performance bonuses, and comprehensive benefits packages may be available.
About IQVIA
IQVIA is a global leader in clinical research, real-world evidence, technology solutions, and healthcare analytics. The organization supports life sciences innovation by accelerating drug development, improving clinical outcomes, and connecting data-driven insights across global markets.
IQVIA is an equal opportunity employer. All qualified applicants will receive consideration without discrimination based on race, color, religion, gender, sexual orientation, gender identity, national origin, disability, or veteran status.
Learn more: jobs.iqvia.com
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