Job Description
Join our pioneering healthcare team at MediTech Research Institute, where innovation meets compassionate care. We're seeking a Senior Clinical Research Coordinator to lead groundbreaking studies in oncology and immunotherapy. You'll collaborate with world-class physicians, manage complex trial protocols, and contribute directly to medical breakthroughs that impact lives globally. Enjoy cutting-edge facilities, comprehensive benefits, and a culture that prioritizes professional growth and work-life balance.
Responsibilities
- Oversee end-to-end clinical trial execution from protocol design to final FDA submission
- Manage site compliance with ICH-GCP guidelines and institutional regulations
- Coordinate multi-disciplinary teams including physicians, data managers, and regulatory affairs specialists
- Develop and maintain comprehensive trial documentation (CRFs, IBs, SOPs)
- Analyze and report adverse events and protocol deviations to ethics committees
- Leverage RAVE EDC for real-time data monitoring and quality assurance
- Mentor junior coordinators and optimize trial workflows
Qualifications
- Master's degree in Clinical Research, Public Health, or related field (or equivalent experience)
- 5+ years' clinical trial coordination experience in oncology/immunotherapy
- Certified Clinical Research Professional (CCRP) or ACRP certification required
- Expertise in FDA 21 CFR Part 11 compliance and electronic data capture systems
- Proven track record of managing Phase II-III trials with 50+ subjects
- Exceptional organizational skills with attention to regulatory nuances
- Strong proficiency in statistical analysis software (SAS/R)
- Experience with global multi-center trials preferred