Job Description
Join our pioneering medical research team at MediGen Innovations, where cutting-edge science meets compassionate care. We're seeking a Senior Clinical Research Coordinator to drive transformative clinical trials in oncology and rare diseases. This role offers the opportunity to work alongside world-class physicians and contribute to breakthrough treatments that impact global healthcare.
Our state-of-the-art facility in Boston's Medical District provides an unparalleled environment for professional growth, competitive compensation, and comprehensive benefits. If you're passionate about accelerating medical innovation while ensuring patient-centric protocols, this is your chance to make a lasting impact.
Responsibilities
- Design, implement, and monitor Phase II-III clinical trials with 15+ concurrent protocols
- Lead FDA/ICH/GCP compliance audits and ensure regulatory documentation accuracy
- Coordinate multi-site collaborations with 5+ international research partners
- Manage complex data collection using EDC systems and validate statistical outcomes
- Mentor junior staff and train investigators on clinical trial methodologies
- Present findings at industry conferences and contribute to peer-reviewed publications
Qualifications
- Master's degree in Clinical Research, Nursing, or related life science field
- 5+ years of clinical trial coordination experience in oncology/rare diseases
- Certified Clinical Research Professional (CCRP) or SOCRA certification
- Proficiency in Oracle Clinical and Rave EDC systems
- Demonstrated success managing FDA inspections and 483 responses
- Strong background in biostatistics and data interpretation methodologies
- Experience with multi-site trial coordination and vendor management