Our client, a pharmaceutical company based in Morristown, New Jersey, is hiring a Clinical Research Associate to oversee clinical trial activities across multiple study sites. This role involves monitoring site compliance, verifying data integrity, and ensuring adherence to protocol and regulatory standards throughout the trial lifecycle.
The ideal candidate has hands-on experience with site monitoring visits, GCP guidelines, and clinical trial documentation. This position works closely with investigators, site coordinators, and internal study teams to keep trials on schedule and in compliance with FDA regulations.
This is a full-time, on-site position offering the opportunity to work on trials spanning multiple therapeutic areas, including oncology and cardiovascular studies.
Responsibilities
- Conduct routine site monitoring visits to assess protocol compliance
- Verify source documentation against case report forms
- Track enrollment status and communicate updates to study leadership
- Ensure informed consent procedures are properly documented
- Review investigational product accountability logs
- Prepare monitoring visit reports and follow-up letters
- Coordinate with site staff to resolve data queries
- Support site initiation, interim, and close-out visits
Requirements
- Bachelor's degree in life sciences, nursing, or related field
- Minimum 3 years of clinical research monitoring experience
- Working knowledge of ICH-GCP guidelines and FDA regulations
- Experience with electronic data capture systems
- Strong attention to detail and documentation accuracy
- Ability to travel to clinical trial sites as needed
- Excellent written and verbal communication skills
- Proficiency with Microsoft Office and clinical trial management software
Benefits
- Medical, dental, and vision insurance
- 401(k) with company match
- Paid time off and company holidays
- Mileage and travel reimbursement
- Life and disability insurance
- Tuition reimbursement program
- Employee assistance program
- Professional development and certification support