Job Description
Join our pioneering clinical research team at Apex Medical Innovations, where we're transforming patient outcomes through groundbreaking therapies. We seek a meticulous Clinical Research Coordinator to manage pivotal trials in oncology and immunology. You'll collaborate with leading physicians, ensure regulatory compliance, and drive data integrity while contributing to life-changing medical advancements. Enjoy competitive compensation, comprehensive benefits, and a culture that values scientific excellence.
Responsibilities
- Oversee all aspects of clinical trial execution from protocol design to final report submission
- Recruit, screen, and enroll eligible patients while maintaining strict ethical standards
- Monitor study sites for compliance with FDA regulations and GCP guidelines
- Manage electronic data capture systems and ensure data accuracy
- Coordinate with investigators, sponsors, and IRB/EC committees
- Prepare regulatory submissions and maintain essential trial documentation
- Analyze trial data and contribute to safety monitoring activities
Qualifications
- Master's degree in Nursing, Public Health, or Clinical Research with 3+ years' experience
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Demonstrated expertise in oncology or immunology clinical trials
- Proficiency in EDC systems (e.g., Medidata Rave, Oracle Inform)
- Strong knowledge of FDA regulations, ICH-GCP, and 21 CFR Part 812
- Exceptional organizational skills and attention to detail
- Ability to work independently while collaborating cross-functionally