Job Description
Join Boston Medical Innovations as a Clinical Research Coordinator and drive transformative healthcare solutions. We're pioneering cutting-edge clinical trials that directly impact patient outcomes, and we need your expertise to ensure regulatory excellence and operational precision. This role offers unparalleled opportunities to collaborate with leading physicians, contribute to FDA-approved protocols, and shape the future of evidence-based medicine.
Our culture values innovation, integrity, and patient-centered care. We provide comprehensive benefits including medical/dental/vision insurance, 401(k) matching, professional development stipends, and flexible work arrangements. If you're passionate about advancing medical research while maintaining the highest ethical standards, this is your chance to make a lasting impact.
Responsibilities
- Design, implement, and manage clinical trial protocols ensuring FDA/ICH/GCP compliance
- Recruit, screen, and enroll study participants while maintaining strict confidentiality standards
- Monitor adverse events and data integrity through electronic health record systems
- Liaise with institutional review boards (IRBs) and regulatory authorities for approvals
- Analyze and report clinical data using SAS and REDCap platforms
- Coordinate multidisciplinary teams including physicians, nurses, and biostatisticians
- Maintain accurate trial documentation per FDA 21 CFR Part 11 requirements
- Present findings at scientific conferences and contribute to peer-reviewed publications
Qualifications
- Bachelor's degree in Nursing, Pharmacy, or Life Sciences (Master's preferred)
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Minimum 3 years of clinical trial coordination experience in therapeutic areas
- Expertise in FDA regulations, GCP guidelines, and electronic data capture
- Advanced proficiency in clinical trial management software (e.g., Medidata Rave)
- Strong statistical literacy with experience in SAS or R programming
- Demonstrated success in managing multi-center studies and complex protocols
- Exceptional communication skills with ability to translate technical concepts