Job Description
Join MedTech Innovations' elite clinical research team at our Boston headquarters where cutting-edge medicine meets compassionate care. We're seeking a Senior Clinical Research Coordinator to drive pivotal studies in oncology and rare diseases. Enjoy state-of-the-art facilities, flexible hybrid work arrangements, and comprehensive benefits including tuition reimbursement and 401(k) matching. Be part of a mission-driven organization transforming patient outcomes through rigorous clinical excellence.
Responsibilities
- Oversee end-to-end clinical trial management from protocol design to FDA submission
- Maintain 100% data integrity through EDC system monitoring and CRF validation
- Spearsite site recruitment and training for multi-center oncology trials
- Ensure GCP/ICH compliance during all trial phases
- Coordinate cross-functional teams including biostatisticians and regulatory affairs
- Generate comprehensive trial reports for sponsor and IRB review
- Mentor junior CRCs and implement process improvements
Qualifications
- Master's degree in Clinical Research, Nursing, or related field
- 5+ years of oncology clinical trial coordination experience
- Certified Clinical Research Professional (CCRP) required
- Advanced proficiency in Oracle Rave and Medidata Rave
- Proven track record in FDA audits and 483 responses
- Strong knowledge of 21 CFR Part 11 and ICH-GCP guidelines
- Experience with rare disease trial design and orphan drug regulations
- Exceptional stakeholder management abilities