Job Description
Join Boston Medical Innovations at the forefront of groundbreaking medical research. We're seeking a passionate Clinical Research Coordinator to drive life-changing clinical trials while ensuring regulatory excellence. Our state-of-the-art facility in Boston's Longwood Medical Area offers unparalleled resources to advance patient care and therapeutic innovations. Enjoy competitive compensation, comprehensive benefits, and a collaborative environment where your expertise directly impacts global health outcomes.
Responsibilities
- Design, implement, and monitor Phase I-III clinical trials per FDA/ICH guidelines
- Recruit, screen, and enroll eligible study participants with precision
- Maintain accurate electronic Case Report Forms (eCRFs) and regulatory documentation
- Coordinate with IRB, sponsors, and investigative sites for protocol compliance
- Analyze trial data and prepare comprehensive regulatory submissions
- Lead cross-functional teams including physicians, nurses, and biostatisticians
- Conduct site visits and ensure GCP standards across all trial activities
Qualifications
- Master's degree in Clinical Research, Nursing, or related health science field
- 3+ years clinical trial coordination experience with oncology focus
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Expertise in FDA regulations, 21 CFR Part 312, and ICH-GCP standards
- Advanced proficiency in clinical trial management systems (e.g., Oracle Inform)
- Proven track record in successful FDA IND/IDE submissions
- Strong analytical skills with experience in statistical data interpretation
- Exceptional communication skills for stakeholder collaboration