SHIFT:

• Adheres to approved recruitment & enrollment strategies
• Maintains regulatory documents per the established protocol or sponsor requirements
• Creates/reviews source documents and sets up study files
• Ensure compliance with protocol guidelines and requirements of regulatory agencies
• Analyzes data through the use of memos, coding and qualitative analytic software
• Assist in the preparation of reports and professional research papers
• Assist in preparation of materials to submit for IRB approval
• Renders age appropriate care & services based on the patient and/or their developmental needs

• High School Diploma / GED Enrollment in school Required
• Bachelor's Degree Preferred

• Internships or paid experiences coordinating research study activities varying size and complexity Required
• Several internships or paid experiences coordinating research study activities varying size and complexity Required
• Pediatric clinical research experience Preferred

• Good written and verbal communication skills
• Able to work in an organized fashion, work well with others
• Good attention to detail
• Proficiency with Microsoft Office applications desirable
• Fully trained on good clinical practices (GCP) and regulatory responsibilities
• Knowledgeable of IRB, FDA, ICH, GCP, or other sources
• Demonstrates the knowledge & ability to render age appropriate care & services based on the patient and/or their developmental needs