Job Description
Join MedTech Innovations at the forefront of medical breakthroughs. We're seeking a passionate Senior Clinical Research Coordinator to drive transformative studies in oncology and rare diseases. Collaborate with world-class physicians, biostatisticians, and regulatory experts in our state-of-the-art Boston facility. Enjoy competitive benefits, professional development stipends, and the opportunity to impact patient lives globally.
Responsibilities
- Design and execute Phase I-III clinical trials ensuring GCP/ICH compliance
- Manage complex data collection systems and validate electronic health record integrations
- Oversee site monitoring activities with 15+ global research partners
- Prepare FDA/EMA submissions and maintain regulatory documentation
- Mentor junior coordinators and optimize trial workflows
- Analyze adverse events and ensure patient safety protocols
- Present findings to ethics committees and pharmaceutical partners
Qualifications
- Master's degree in Clinical Research, Nursing, or related field
- 5+ years of clinical trial coordination in oncology or rare diseases
- Certified Clinical Research Professional (CCRP) certification required
- Advanced proficiency in Medidata Rave and Oracle CTMS
- Demonstrated experience with FDA 1572 and ICF documentation
- Strong knowledge of 21 CFR Part 11 and HIPAA compliance
- Exceptional problem-solving skills in cross-functional team environments