Job Description
Join Mayo Clinic's elite clinical research team as a Senior Clinical Research Coordinator, driving innovation in patient care through groundbreaking trials. You'll manage complex oncology studies from protocol design to FDA submission, collaborating with world-class physicians and biotech partners. This role offers unparalleled opportunities to shape the future of precision medicine while advancing your career in one of America's top healthcare institutions.
Responsibilities
- Oversee multi-site oncology clinical trials ensuring GCP/ICH compliance and protocol adherence
- Lead site initiation visits, monitor trial progress, and conduct source document verification
- Develop and maintain comprehensive regulatory documentation (INDs, IRB submissions, adverse event reporting)
- Mentor junior coordinators and train clinical staff on research procedures
- Analyze interim data and prepare FDA-ready study reports and publications
- Collaborate with biostatisticians on protocol design and statistical analysis plans
- Manage investigational product inventory and ensure proper cold chain maintenance
Qualifications
- Master's degree in Nursing, Life Sciences, or related field with 5+ years clinical research experience
- Certified Clinical Research Professional (CCRP) or equivalent certification required
- Proven expertise in oncology trial management with FDA audit experience
- Advanced proficiency in electronic data capture systems (e.g., Medidata Rave, Oracle Clintrial)
- Exceptional knowledge of ICH-GCP, FDA 21 CFR Part 312, and international regulations
- Demonstrated success in leading complex multi-center studies with 10+ sites
- Strong data management skills including SAS or R programming experience
- Excellent communication abilities for stakeholder engagement and regulatory interactions