Clinical Research Associate (CRA 2) – CAR-T | IQVIA Biotech
Location: Durham, North Carolina
Employment Type: Full-Time
Job ID: R1481904
Work Model: Field-Based
Additional Locations Available Across the United States
Overview
IQVIA Biotech is seeking an experienced Clinical Research Associate (CRA 2) with hands-on CAR-T monitoring experience and a minimum of one year of on-site clinical monitoring. As a specialized division built exclusively to support biotech sponsors, IQVIA Biotech delivers agile and therapeutically aligned clinical solutions designed to accelerate the development of innovative therapies.
This role supports the successful execution of clinical trials by overseeing site compliance, ensuring adherence to study protocols, and maintaining the integrity of clinical data.
Key Responsibilities
Conduct comprehensive site visits, including pre-study, initiation, routine monitoring, and close-out, in alignment with ICH guidelines, GCP standards, and contracted project scope.
Collaborate with site teams to drive subject recruitment strategies and ensure alignment with study timelines and enrollment objectives.
Provide protocol training and study-specific guidance to site staff while maintaining consistent communication to address operational challenges.
Evaluate site performance, verify protocol adherence, and escalate quality concerns as needed to protect data integrity and regulatory compliance.
Monitor overall study progress by tracking regulatory submissions, patient enrollment, CRF completion, and timely resolution of data queries.
Ensure timely and accurate collection of essential regulatory documents for the Trial Master File (TMF) and Investigator Site File (ISF).
Prepare detailed monitoring reports, follow-up letters, and documentation outlining site visit findings and required corrective actions.
Collaborate with cross-functional study teams to ensure operational alignment and support efficient project execution.
Depending on project requirements, support site-level financial tracking, including invoice management and budget-related coordination.
Qualifications
Bachelor’s degree in life sciences, healthcare, or an equivalent discipline.
Minimum 1 year of on-site monitoring experience, including experience working with CAR-T clinical studies.
Strong understanding of Good Clinical Practice (GCP), ICH guidelines, and global regulatory standards.
Ability to travel as required for site oversight and study support.
About IQVIA
IQVIA is a global leader in clinical research, data analytics, and healthcare intelligence. The organization partners with life science innovators to accelerate the development and delivery of advanced medical treatments aimed at improving patient outcomes worldwide.
IQVIA is an equal opportunity employer and considers all qualified applicants without regard to protected characteristics.
Compensation
Estimated Annual Base Pay Range:
$57,500 – $174,400
Actual pay depends on factors such as relevant experience, education, skills, geographic location, and scheduled work hours. Additional benefits, performance incentives, and compensation programs may be available based on the role.
Gujarat :
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Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | Newark | New Brunswick | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | Westfield | West Orange | Wharton | Whippany |Ohio :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Arkansas | Remote Australia |New South Wales :
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Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
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Niš |Bohemia :
Prague |Chile :
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