Raquel Celani
Sterling Heights
Summary
Experienced Clinical Research Coordinator with 24 years in human subject oversight and regulatory compliance. Led the transition to electronic systems in 21 hospitals, ensuring protocol adherence. Specializes in patient recruitment, data analysis, and good clinical practices, with strong skills in data analytics and proficiency in iMedRIS, OneAegis, and Microsoft Office Suite.
Overview
30
30
years of professional experience
Work History
Clinical Research Coordinator II
Corewell Health
Royal Oak
07.1996 - Current
- Evaluate human subject research for regulatory compliance across all studies.
- Review new study submissions, revisions to approved studies and closures.
- Oversee electronic submission system transition from iMedRIS to OneAegis, serving as lead and point of contact for both systems.
- Coordinate submission distribution upon receipt from electronic systems.
- Manage Corewell Health IRB intranet, providing 21 hospitals with timely updates on policies and processes.
- Conduct audits of electronic systems, ensuring integrity and compliance with regulatory standards.
- Maintain organization’s FWA and OHRP updates, supporting ongoing education efforts.
- Execute payroll processing to guarantee that all employees receive their compensation on schedule.
- Proficient in iMedRIS, OneAegis, OneNote, Excel, Word, PowerPoint, SharePoint, Kronos, etc.
Education
Certified IRB Professional (CIP) - Human Research Protections
Public Responsibility in Med/Research
Boston, MA01-2016
Certified Clinical Research Professional (CCRP) - Clinical Research Professional
Society of Clinical Research Excellence
Brentwood, TN11-2015
High School Diploma -
Hazel Park High School
Hazel Park, MI06-1996
Skills
- Regulatory compliance
- Good clinical practice
- Submission management
- Protocol development
- Electronic systems auditing
- Data integrity assurance
- Quality assurance
- Ethics administration
- Subject protection
- Report preparation
- Documentation management
- Research experience
- Data analysis
- Data capture
- Records maintenance
- SOPs understanding
- Process improvement
- Project coordination
- Scheduling proficiency
- Meeting coordination
- Database organization
- Attention to detail
- Time management
- Team collaboration
- Strong communication
- Effective communication
- Problem solving
- Critical thinking
- Adaptability
- Environment establishment
- Collection techniques
- Relationship building
- Detailed documentation
- Problem-solving
- Environment establishment
- Collection techniques
Timeline
Clinical Research Coordinator II
Corewell Health
07.1996 - Current
Certified IRB Professional (CIP) - Human Research Protections
Public Responsibility in Med/Research
Certified Clinical Research Professional (CCRP) - Clinical Research Professional
Society of Clinical Research Excellence
High School Diploma -
Hazel Park High School