Clinical Research Associate - New York / New Jersey
$112,154–$168,232 year
On-site · New York City, New York, United States
Job Summary
Clinical Research Associate located in New York or New Jersey; responsible for delivering studies at allocated sites, acting as main site contact, and monitoring study conduct in compliance with ICH-GCP and local regulations. Manages site qualification, regulatory submissions to EC/IRB, site training, and ensuring inspection readiness. Maintains and updates CTMS and eTMF, conducts remote/on-site monitoring, SDV/SDR/CRF reviews, quality risk assessments, and escalation of issues. Collaborates with Local Study Team and Local Study Manager, supports audits and regulatory inspections, and ensures data integrity and timely reporting of Serious Adverse Events. Requires travel, strong attention to detail, and knowledge of AZ SOPs.
Required Qualifications
- Bachelor's degree in related discipline
- Excellent knowledge of international guidelines ICH-GCP
- Basic knowledge of GMP/GDP
- Good knowledge of relevant local regulations
- Good medical knowledge and ability to learn relevant AZ Therapeutic Areas
- Basic understanding of the drug development process
- Good understanding of Clinical Study Management including monitoring, study drug handling and data management
- Excellent attention to details
- Good written and verbal communication skills
- Good collaboration and interpersonal skills
- Good negotiation skills
- Ability to travel nationally/internationally as required
- Valid driving license
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