Clinical Research Associate (CRA) – Sponsor Dedicated
Location: Parsippany, New Jersey, United States
Work Model: Field-Based
Job Type: Full-Time
Job ID: R1507163
About the Role
This Sponsor-Dedicated Clinical Research Associate (CRA) position involves monitoring, oversight, and site management activities to ensure clinical trial sites adhere to the study protocol, regulatory guidelines, and sponsor expectations. This role plays a key part in ensuring study quality, subject safety, and accurate data collection across assigned investigational sites.
Key Responsibilities
• Conduct site monitoring activities including site selection, initiation, routine monitoring, and close-out visits as per ICH-GCP, regulatory standards, and project scope.
• Support sites in implementing and tracking subject recruitment strategies to meet enrollment targets.
• Provide protocol-specific and study-related training to site personnel and maintain consistent communication to manage expectations and resolve operational issues.
• Evaluate site practices for protocol compliance, regulatory adherence, and data accuracy; escalate quality concerns as required.
• Track clinical trial progress including regulatory submissions, enrollment, CRF completion, and data query resolution.
• Ensure required site documents are accurately filed in the Trial Master File (TMF) and Investigator Site File (ISF) per GCP and local regulatory guidelines.
• Prepare documentation such as visit reports, follow-up letters, and site management records.
• Collaborate closely with cross-functional study teams to support study execution.
• If applicable, support site-level recruitment strategy development and site financial management activities.
Qualifications and Experience Required
• Bachelor’s degree in a scientific or healthcare-related discipline preferred.
• Equivalent education and relevant clinical research training may be considered.
• Prior experience as a CRA or completion of a recognized CRA training program preferred.
• Strong understanding of GCP, ICH guidelines, and clinical research regulatory requirements.
• Working knowledge of clinical trial protocols and therapeutic area processes.
• Proficiency in Microsoft Word, Excel, PowerPoint, and use of laptops and mobile devices.
• Excellent written and verbal communication skills with strong command of English.
• Strong organizational, analytical, and problem-solving abilities.
• Effective time and financial management capabilities.
• Ability to build and maintain strong professional relationships with site staff, team members, and sponsors.
Experience Level
• 1–3 years of clinical research monitoring experience preferred, or
• CRA training certification with relevant clinical research exposure.
About IQVIA
IQVIA is a global leader in clinical research, real-world evidence, and healthcare intelligence. Through advanced analytics and innovative solutions, IQVIA supports the development and commercialization of life-changing medical treatments worldwide.
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