Clinical Research Associate – Sponsor Dedicated
Location: Parsippany, New Jersey | Full-Time | Field-Based
Job ID: R1507163
Additional Locations Available
Position Overview
The Sponsor-Dedicated Clinical Research Associate (CRA) is responsible for monitoring clinical trial sites to ensure compliance with study protocols, regulatory guidelines, and sponsor expectations. This role supports site management activities across the study lifecycle, ensuring high-quality data collection, subject safety, and adherence to Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) standards.
Key Responsibilities
Conduct site monitoring visits, including selection, initiation, routine monitoring, and close-out activities, in accordance with project scope and regulatory requirements.
Partner with clinical sites to drive and monitor subject recruitment plans, ensuring study timelines and enrollment goals are met.
Provide protocol and study-specific training to study sites and maintain ongoing communication to support compliance and issue resolution.
Assess the quality, integrity, and operational conduct of investigational sites; escalate quality concerns when required.
Track and manage study progress, including regulatory submissions, site approvals, patient recruitment, CRF completion, data queries, and overall site performance.
Ensure all required site documents are collected, verified, and filed appropriately within the Trial Master File (TMF) and that Investigator Site Files (ISF) adhere to GCP/ICH and local regulations.
Prepare accurate and timely visit reports, follow-up letters, and site management documentation.
Collaborate with project team members to support successful study execution and site performance.
Support development of site-specific recruitment strategies when applicable.
Manage site financials, including invoice tracking and adherence to clinical trial agreements when assigned.
Required Qualifications & Experience
Bachelor’s degree in a scientific or healthcare discipline preferred.
Equivalent education, training, or experience may be considered in place of a degree.
Completion of a formal CRA training program or prior monitoring experience preferred by some organizations.
Experience Requirement: Entry-level to experienced candidates are accepted; monitoring experience is advantageous.
Solid understanding of GCP, ICH guidelines, and clinical research regulatory requirements.
Strong therapeutic and protocol knowledge (company training provided).
Proficiency with Microsoft Word, Excel, PowerPoint, and standard clinical research technology, including laptops and mobile devices.
Excellent written and verbal communication skills in English.
Strong organizational, problem-solving, time management, and financial tracking skills.
Ability to build and maintain effective working relationships across teams, sites, and stakeholders.
Compensation
Annual Base Pay Range: USD 71,900 – 189,000
Actual compensation may vary based on qualifications, skills, experience, location, and schedule. Additional incentives, bonuses, and benefits may be offered depending on the role.
About IQVIA
IQVIA is a global leader in clinical research services, advanced analytics, and healthcare intelligence. The company partners with life sciences organizations to accelerate the development of innovative treatments and improve patient outcomes worldwide.
IQVIA is an equal opportunity employer committed to diversity and inclusion.
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