Job Description
Join Boston Medical Innovations, a leader in cutting-edge clinical trials, as a Clinical Research Coordinator. We're seeking a meticulous professional to oversee complex medical research protocols and ensure compliance with FDA regulations. This role offers the opportunity to contribute to groundbreaking treatments while working in our state-of-the-art facility in Boston's Longwood Medical Area.
Our team fosters a collaborative environment where your expertise directly impacts patient outcomes and medical innovation. We offer competitive compensation, comprehensive benefits, and opportunities for professional growth in one of America's most prestigious healthcare hubs.
Responsibilities
- Manage all aspects of clinical trial protocols including patient recruitment, screening, and informed consent processes
- Maintain accurate electronic and paper documentation ensuring 100% regulatory compliance (FDA, GCP)
- Coordinate with multidisciplinary teams including physicians, nurses, and data specialists
- Monitor adverse events and ensure timely reporting to IRB and sponsors
- Conduct site initiation, monitoring, and closeout visits per SOPs
- Analyze and report clinical data using EDC systems (e.g., Medidata Rave)
- Maintain budget tracking and vendor management for assigned studies
Qualifications
- Bachelor's degree in life sciences, nursing, or related field (Master's preferred)
- Certified Clinical Research Professional (CCRP) or equivalent certification required
- Minimum 3 years experience in clinical trials with therapeutic area expertise in oncology
- Proficiency in EDC systems and regulatory documentation software
- Demonstrated knowledge of FDA 21 CFR Part 312 and ICH-GCP guidelines
- Exceptional organizational skills with attention to detail in high-pressure environments
- Strong communication abilities for stakeholder engagement and conflict resolution
- Valid CPR certification