Rare Disease Clinical Research Coordinator Resume
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Professional Summary
A highly skilled and dedicated Clinical Research Coordinator with over 5 years of experience in managing clinical trials and research projects focused on rare diseases. Expert in regulatory compliance, data collection, patient recruitment, and coordinating interdisciplinary teams. Passionate about advancing rare disease research and ensuring the efficient execution of clinical studies to improve patient outcomes.
Skills
Clinical Research Coordination
Regulatory Compliance & Ethics
Patient Recruitment & Retention
Data Management & Analysis
GCP (Good Clinical Practice)
Protocol Development & Implementation
Medical Terminology & Documentation
Team Collaboration & Communication
Problem-Solving & Decision-Making
Clinical Trial Monitoring
Professional Experience
Clinical Research Coordinator
Rare Disease Research Institute, City, State
March 2060 – Present
Coordinate and manage clinical trials for rare disease studies, including recruitment, enrollment, and retention of participants.
Ensure compliance with regulatory requirements, including IRB submissions, FDA regulations, and GCP guidelines.
Collect, manage, and analyze data, ensuring accuracy and integrity for submission to sponsors and regulatory bodies.
Serve as the primary liaison between patients, research teams, and external stakeholders, providing support and information throughout the clinical trial process.
Conduct patient assessments, including pre-screening, medical history review, and ongoing health monitoring during trials.
Maintain detailed records and documentation of trial activities in compliance with federal and institutional policies.
Clinical Research Assistant
BioResearch Solutions, City, State
June 2057 – February 2060
Assisted in the design, implementation, and management of clinical trials focused on rare genetic disorders.
Supported patient recruitment efforts, screening potential participants, and managing informed consent processes.
Monitored patient progress, documenting any adverse events and ensuring they were reported per protocol.
Collaborated with the principal investigator and clinical research teams to ensure project milestones were met.
Prepared regulatory documents for review by ethics committees and funding agencies.
Education
Master of Science in Clinical Research
University of Health Sciences, City, State
Graduated: May 2057
Bachelor of Science in Biology
State University, City, State
Graduated: May 2055
Certifications & Licenses
Certified Clinical Research Coordinator (CCRC) – Association of Clinical Research Professionals (ACRP)
Good Clinical Practice (GCP) Certification – National Institutes of Health (NIH)
Human Subjects Protection Certification – Collaborative Institutional Training Initiative (CITI)
Research Experience
Rare Disease Gene Therapy Trial
Lead Research Coordinator
Rare Disease Research Institute
June 2061 – Present
Managed a multi-center clinical trial focusing on gene therapy for a rare neurodegenerative disease.
Coordinated with genetic counselors, physicians, and laboratory staff to facilitate patient care and research progress.
Analyzed and documented clinical outcomes, collaborating with statisticians to prepare findings for publication.
Publications
Doe, J., et al. "Advancements in Gene Therapy for Rare Neurodegenerative Diseases," Journal of Rare Diseases Research, Volume 12, Issue 4, 2063.
Doe, J., et al. "A Clinical Trial on the Efficacy of Stem Cells in Treating Rare Muscular Dystrophy," Clinical Trials in Rare Diseases, 2062.
References
Available upon request.
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