Our client, a pharmaceutical company, is seeking a Clinical Research Associate to support the planning, execution, and monitoring of clinical trials at their State College facility. This role works closely with investigators, site staff, and internal quality teams to ensure studies are conducted in compliance with protocol requirements and regulatory standards.
The Clinical Research Associate will manage assigned trial sites, review study documentation, and track progress against enrollment and data collection timelines. This position requires regular site visits, close attention to regulatory detail, and clear communication with cross-functional teams including data management, regulatory affairs, and clinical operations.
This is a full-time, on-site position offering the opportunity to work on a range of therapeutic areas within a structured clinical development environment.
Responsibilities
- Conduct site visits to monitor trial progress and data quality
- Review case report forms for accuracy and completeness
- Verify adherence to protocol, GCP, and applicable regulations
- Maintain trial master files and ensure documentation is audit-ready
- Coordinate with investigators and site coordinators on study logistics
- Track patient enrollment and report on study milestones
- Assist in resolving data queries and protocol deviations
- Prepare monitoring visit reports and follow-up action items
Requirements
- Bachelor's degree in life sciences, nursing, or related field
- Minimum 5 years of clinical research or monitoring experience
- Working knowledge of ICH-GCP guidelines and FDA regulations
- Experience with electronic data capture systems
- Strong organizational skills and attention to detail
- Ability to travel to trial sites as needed
- Excellent written and verbal communication skills
- CCRA or similar certification preferred
Benefits
- Medical, dental, and vision insurance
- 401(k) with company match
- Paid time off and company holidays
- Life and disability insurance
- Tuition and certification reimbursement
- Employee assistance program
- Mileage and travel reimbursement
- Professional development opportunities