Clinical Research Coordinator
Professional Resume Example
Professional Summary
Highly organized and detail-oriented Clinical Research Coordinator with 4+ years of experience managing Phase II/III clinical trials across oncology and cardiology. Proficient in GCP, ICH guidelines, participant recruitment, and data management using EDC systems like Medidata Rave and REDCap. Proven ability to ensure protocol adherence, maintain meticulous regulatory documentation, and facilitate successful study outcomes from startup to closeout.
Work Experience
Clinical Research Coordinator II
Horizon Pharma Research
- Coordinated 4 concurrent Phase III clinical trials in oncology, ensuring 100% protocol adherence and achieving a 95% participant retention rate over a 2-year period.
- Screened, consented, and enrolled an average of 10-15 new participants per quarter, consistently exceeding recruitment targets by 10% for designated studies.
- Managed comprehensive clinical data entry and query resolution for 50+ active participants using Medidata Rave EDC, maintaining data integrity with zero significant discrepancies during monitoring visits.
- Prepared and submitted 15+ regulatory documents, including initial IRB submissions, amendments, and annual reviews, ensuring timely approvals with zero compliance findings.
- Facilitated 12+ successful sponsor and CRO monitoring visits annually, addressing all queries within a 24-hour turnaround and contributing to positive audit outcomes.
Clinical Research Coordinator I
Bayview Medical Center
- Supported 3 Phase II cardiology trials, assisting with participant scheduling, follow-up visits, and accurate data collection for over 80 active subjects.
- Maintained electronic and paper regulatory binders for 5 active studies, ensuring all documents were audit-ready and compliant with GCP and FDA regulations.
- Administered informed consent processes for new participants, ensuring complete understanding and voluntary participation for 100% of enrolled subjects.
- Utilized REDCap for source data capture and managed minor data queries, achieving a 98% data completeness rate across all assigned projects.
- Reported 20+ adverse events and serious adverse events to sponsors and IRBs within required timelines, documenting all follow-up actions meticulously.
Skills
Education
Bachelor of Science in Public Health
University of California, Berkeley
Certifications
- • Certified Clinical Research Coordinator (CCRC) – Association of Clinical Research Professionals (ACRP)
- • Good Clinical Practice (GCP) Certification – CITI Program
- • Basic Life Support (BLS) Certification – American Heart Association
Frequently Asked Questions
What certifications are most valuable for a Clinical Research Coordinator?
The Certified Clinical Research Coordinator (CCRC) from ACRP or SoCRA is highly regarded. Additionally, up-to-date Good Clinical Practice (GCP) certification is fundamental and often a prerequisite. These certifications demonstrate a commitment to professional standards and a strong understanding of essential regulations and practices in clinical research.
How can I stand out if I have limited CRC experience?
Focus on transferable skills from previous roles like meticulous organization, attention to detail, strong communication, and regulatory adherence. Highlight any coursework in public health, biology, or nursing. Emphasize volunteer experience in healthcare or research settings and obtain your GCP certification to show proactive engagement with the field.
Should I include soft skills on my CRC resume?
Yes, absolutely. While technical skills are vital, soft skills like excellent communication, empathy, problem-solving, teamwork, and adaptability are crucial for a CRC who interacts with participants, investigators, and sponsors daily. Weave these into your summary and achievements to show your holistic capability.