Clinical Research Integrity Coordinator
Temple Health – Temple University Health System · Philadelphia, PA · 3 wk ago
AnalystFull-time
About the role
The Research Quality Assurance Analyst reviews clinical trial research requirements for compliance with FDA and other regulatory bodies, ensuring accuracy and completeness of data and participant safety.
Responsibilities
- Serve as a resource for OCR staff on compliance and ICH-GCP guidelines
- Audit pharmaceutical preparations and provide responses
- Perform eligibility verifications and chart reviews
- Coordinate projects and communicate status to leadership
- Implement and coordinate department-wide initiatives related to research quality management or clinical trial education
Requirements
- Bachelor's Degree in relevant field required
- One year experience in a healthcare environment as a Clinical Research Associate, Clinical Research Coordinator, Clinical Research Nurse, or Medical Chart Auditor required
- Two years experience in clinical trials auditing preferred
- Two years experience in oncology preferred
Qualifications
- Clinical Research Coordinator certification preferred
- Clinical Research Associate certification preferred
- Clinical Research Professional certification preferred
- Association of Clinical Research Professionals certification preferred
- PA Registered Nurse license preferred
- PA Practical Nurse license preferred