1
Professional Summary
“Clinical research coordinator with 4+ years managing Phase II-IV clinical trials across oncology and cardiology therapeutic areas. Experienced in patient recruitment, protocol compliance, regulatory submissions, and data management with a track record of meeting enrollment timelines and maintaining audit-ready documentation.”
2
Key Skills
Clinical Trial ManagementIRB/Ethics CommitteePatient RecruitmentProtocol ComplianceEDC Systems (Medidata, REDCap)Informed ConsentAdverse Event ReportingGCP/ICH GuidelinesRegulatory SubmissionsSite MonitoringHIPAA Compliance
3
Sample Experience Bullets
- Managed 8 concurrent Phase II-III trials with 200+ patients enrolled. Met enrollment targets within 5% of timeline
- Passed 5 FDA audits and 15 sponsor monitoring visits with 100% compliance. Documentation was always audit-ready
- Improved enrollment rates by 40% through community outreach events and building a physician referral network
- Processed 500+ adverse event reports with 100% on-time submission to sponsors and the IRB
- Trained 6 junior coordinators on GCP guidelines, EDC systems, and informed consent procedures
- Responsible for scheduling patient visits, collecting specimens, and entering data into the EDC system (Medidata Rave)
- Worked with the PI to review protocol amendments and implement changes across all active study sites
- Managed the regulatory binder for each study including IRB correspondence, consent form versions, and delegation logs
- Coordinated with the pharmacy on study drug accountability, randomization, and proper storage and handling
4
ATS Keywords
Include these keywords in your resume to pass Applicant Tracking Systems.
clinical research coordinatorCRCclinical trialresearch coordinatorpatient enrollmentIRBGCPprotocol compliancesite managementregulatory
5
Recommended Certifications
- CCRC (Certified Clinical Research Coordinator)
- CITI Good Clinical Practice
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