Clinical Research Associate (CRA) – Sponsor Dedicated
Location: Parsippany, New Jersey, USA
Additional Locations: California, North Carolina, Kansas, New Jersey, Remote
Job Type: Full-Time
Job ID: R1507163
About the Role
The Sponsor-Dedicated Clinical Research Associate (CRA) is responsible for conducting monitoring and site management activities to ensure accurate study execution, regulatory compliance, and high-quality data collection in accordance with protocol and sponsor requirements. This field-based role supports the operational delivery of clinical trials across multiple therapeutic areas.
Key Responsibilities
Conduct site monitoring visits, including site selection, initiation, routine monitoring, and close-out visits, as per project scope and regulatory standards such as GCP and ICH guidelines.
Drive and track subject recruitment activities in alignment with project timelines and enrollment targets.
Provide protocol training and study-specific guidance to assigned sites, establishing consistent communication to manage expectations and resolve issues.
Assess study site performance, quality, and adherence to protocol and regulatory requirements, escalating quality concerns as necessary.
Track study progress, including regulatory submissions, approvals, recruitment, enrollment, CRF completion, data query resolution, and other operational metrics.
Ensure required site documents are available for the Trial Master File (TMF) and that the Investigator Site File (ISF) complies with GCP/ICH and local regulatory standards.
Prepare and maintain detailed documentation of all monitoring activities, including visit reports, follow-up letters, and corrective action plans.
Collaborate with cross-functional study teams to support clinical project execution.
Contribute to development and tracking of site-level recruitment strategies, when applicable.
Support site-level financial management and invoice reconciliation in accordance with clinical trial agreements, where required.
Required Qualifications & Experience
Education: Bachelor’s degree in a scientific, healthcare, or life sciences discipline preferred.
Experience:
Previous clinical monitoring experience or completion of a recognized CRA training program is preferred.
Solid understanding of GCP, ICH guidelines, and other applicable regulatory requirements.
Proficiency with Microsoft Word, Excel, PowerPoint, and digital tools such as laptop, iPhone, and iPad (as applicable).
Strong communication skills with excellent command of the English language.
Strong organizational abilities, problem-solving skills, and attention to detail.
Effective time management and financial awareness related to site budgeting.
Proven ability to build and maintain professional relationships with site staff, sponsors, and internal teams.
About the Company
IQVIA is a global leader in clinical research, data science, and healthcare intelligence. The company provides advanced solutions that accelerate drug development, enhance commercial performance, and improve patient outcomes worldwide.
Compensation
The annualized base pay range for this role is $71,900 – $189,000, depending on factors such as experience, location, education, and job-related skills. Additional compensation may include incentive plans, bonuses, and comprehensive health and welfare benefits.
Equal Employment Opportunity
IQVIA is an equal opportunity employer. All applicants will be considered without discrimination based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, veteran status, or any other characteristic protected by applicable law.
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