Job Description
Join Boston Medical Innovations as a Clinical Research Coordinator and become a pivotal force in advancing medical breakthroughs. We're seeking a meticulous professional to orchestrate complex clinical trials while ensuring regulatory compliance and data integrity. This role offers unparalleled opportunities to collaborate with leading physicians, biotech startups, and global pharmaceutical partners in Boston's premier medical ecosystem.
Our state-of-the-art facilities in the Longwood Medical Area provide an inspiring environment where your expertise directly impacts patient care innovation. We offer competitive benefits, professional development stipends, and a culture that values scientific rigor and compassionate patient advocacy.
Responsibilities
- Design and execute clinical trial protocols in compliance with FDA regulations and ICH-GCP guidelines
- Manage participant recruitment, screening, and retention strategies for diverse patient populations
- Maintain accurate electronic Case Report Forms (eCRFs) and ensure data quality through rigorous source verification
- Coordinate interdisciplinary research teams including principal investigators, nurses, and biostatisticians
- Oversee regulatory documentation including IRB submissions, consent forms, and adverse event reporting
- Analyze preliminary trial data and prepare comprehensive progress reports for stakeholders
- Implement risk-based monitoring strategies to optimize trial efficiency and participant safety
Qualifications
- Master's degree in Clinical Research, Nursing, Life Sciences, or related field (or equivalent experience)
- 3+ years of clinical trial coordination experience in therapeutic areas (oncology preferred)
- Certified Clinical Research Professional (CCRP) or ACRP certification required
- Proficiency in clinical trial management systems (e.g., Medidata Rave, Oracle InForm)
- Demonstrated knowledge of FDA 21 CFR Part 11 and HIPAA compliance
- Exceptional attention to detail with proven track record in data management
- Strong written and verbal communication skills for regulatory documentation and team collaboration
- Experience with site initiation visits and monitoring visits in academic/hospital settings