Job Description
Join Boston Medical Innovations as a Clinical Research Coordinator and drive breakthroughs in healthcare innovation. We're seeking a meticulous professional to manage clinical trials, ensuring compliance with FDA regulations and ethical standards. Collaborate with multidisciplinary teams to advance medical treatments while maintaining patient safety and data integrity. This role offers competitive compensation, comprehensive benefits, and opportunities for professional growth in Boston's thriving healthcare ecosystem.
Responsibilities
- Oversee clinical trial protocols, ensuring adherence to Good Clinical Practice (GCP) guidelines
- Coordinate patient recruitment, informed consent processes, and study visits
- Manage electronic data capture systems and maintain accurate regulatory documentation
- Liaise with investigators, sponsors, and IRB committees for protocol compliance
- Analyze study data and prepare comprehensive progress reports for stakeholders
- Maintain inventory of investigational products and ensure proper storage/disposal
- Train site staff on study procedures and regulatory requirements
Qualifications
- Bachelor's degree in Nursing, Life Sciences, or related field (Master's preferred)
- 2+ years clinical research coordination experience in FDA-regulated trials
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proficiency in electronic data capture systems (e.g., Medidata Rave, Oracle Inform)
- Deep knowledge of ICH-GCP, FDA 21 CFR Part 812, and HIPAA regulations
- Exceptional organizational skills with attention to detail and documentation
- Strong interpersonal abilities to collaborate with diverse stakeholders
- Ability to manage multiple studies in a fast-paced environment