Job Description
Join our pioneering clinical research team at MediTech Innovations, where cutting-edge medical discoveries meet compassionate patient care. We're seeking a Senior Clinical Research Coordinator to lead complex oncology trials at our state-of-the-art Boston facility. This role offers unparalleled opportunities to shape the future of precision medicine while working with world-renowned physicians and advanced research technologies.
Responsibilities
- Design, implement, and monitor Phase II-III oncology clinical trials per FDA and ICH guidelines
- Manage study budgets, timelines, and resource allocation for multi-center trials
- Coordinate with IRB, regulatory agencies, and investigative sites for compliance
- Train and mentor junior CRCs and research assistants on GCP protocols
- Analyze adverse events and safety data using EDC systems (e.g., Medidata Rave)
- Present trial results at investigator meetings and scientific conferences
- Collaborate with biostatisticians on protocol development and endpoint validation
Qualifications
- Master's degree in Clinical Research, Nursing, or related health field
- 5+ years of oncology clinical trial coordination experience
- Certified Clinical Research Professional (CCRP) or ACRP-CP certification
- Expertise in oncology protocols, GCP, and 21 CFR Part 820 compliance
- Advanced proficiency in EDC systems and electronic source documentation
- Strong statistical knowledge for protocol design and data interpretation
- Exceptional communication skills for multi-stakeholder coordination
- Experience managing FDA audits and regulatory submissions