Details:
- Compensation: $65,000 - $75,000k
- Benefits: Medical, Dental, Vision
- Employment Classification: Direct Hire
- Status: On-Site
- Job ID: 20775
Key Responsibilities
- Conduct routine quality audits of study files, source documents, and regulatory binders
- Review CRFs and EDC entries for accuracy, completeness, and protocol compliance
- Monitor adherence to ICH-GCP guidelines, FDA regulations, and institutional SOPs
- Serve as liaison for sponsor monitoring visits, audits, and regulatory inspections
- Track and ensure timely resolution of audit findings, CAPAs, and data queries
- Oversee investigational product accountability and temperature monitoring logs
- Identify protocol deviations, document trends, and implement corrective actions
- Develop and maintain site SOPs, quality metrics, and training materials
- Support adverse event reporting and informed consent process quality checks
Required Qualifications
- Bachelor's degree in life sciences, nursing, or healthcare-related field
- Minimum 2 years clinical research or healthcare quality/compliance experience
- Strong knowledge of ICH-GCP, FDA regulations (21 CFR Parts 50, 56, 312), and HIPAA
- Experience with EDC systems (Medidata Rave, Oracle InForm, REDCap, or similar)
- Exceptional attention to detail and audit-ready documentation practices
- Strong analytical and problem-solving skills