Rachel Carter

• Phone: +1 917 555 0123
• Email: rachel.carter@email.com
• Location: New York, USA
• LinkedIn: rachelcartercrc

Summary

Over 7 years of experience in coordinating clinical trials across various therapeutic areas, ensuring strict adherence to protocols and regulatory guidelines. Successfully managed patient recruitment and retention for multi-site studies, consistently exceeding enrollment targets by an average of 15%. Proficient in data collection, adverse event reporting, and maintaining comprehensive study documentation to support research integrity.

Experience

Senior Clinical Research Coordinator, Mount Sinai Health System -- New York, USA

Aug 2019 – present

• Orchestrated the successful execution of 8 Phase II/III clinical trials in oncology and infectious diseases, maintaining 100% compliance with FDA regulations and GCP guidelines.

• Developed and implemented patient recruitment strategies that increased enrollment rates by 20% for challenging studies.

• Managed and trained a team of 3 junior research assistants, improving data quality and reducing query rates by 25%.

• Authored and revised study protocols, informed consent forms, and case report forms (CRFs) for investigator-initiated trials.

• Conducted comprehensive monitoring visits and audits, ensuring accuracy and completeness of source documentation and regulatory binders.

Clinical Research Coordinator, NewYork-Presbyterian Hospital -- New York, USA

Mar 2016 – July 2019

• Coordinated 5 clinical trials in cardiology and neurology, responsible for patient screening, enrollment, and scheduling of study visits.

• Collected and entered clinical data into Electronic Data Capture (EDC) systems, achieving a data entry accuracy rate of 98%.

• Processed and shipped biological samples according to IATA regulations and study-specific protocols.

• Educated patients and their families about study procedures, potential risks, and benefits, ensuring informed consent.

• Maintained accurate and up-to-date regulatory documents, including IRB submissions and approvals.

Education

New York University, Master of Public Health (MPH) in Public Health -- New York, USA

Sept 2014 – May 2016

State University of New York at Albany, Bachelor of Science (BS) in Biological Sciences -- Albany, USA

Sept 2010 – May 2014

Skills

Clinical Research Operations: GCP, FDA Regulations, IRB Submissions, Protocol Development, Patient Recruitment & Retention, Data Management, EDC Systems (Medidata Rave, Oracle Clinical), Adverse Event Reporting, Regulatory Affairs, Site Monitoring, Quality Assurance

Technical & Software: Microsoft Office Suite (Word, Excel, PowerPoint), REDCap, Electronic Health Records (Epic), Statistical Analysis Software (basic R/SAS)

Interpersonal & Communication: Patient Education, Cross-functional Team Collaboration, Stakeholder Communication, Problem-Solving, Organizational Skills, Attention to Detail

Certifications: Certified Clinical Research Coordinator (CCRC), GCP Certified, IATA Dangerous Goods Regulations