Job Description
Join Boston Medical Innovations, a leader in cutting-edge clinical research, as we pioneer breakthrough treatments in oncology and rare diseases. We're seeking a meticulous Clinical Research Coordinator to orchestrate multi-center trials, ensuring compliance and excellence throughout the research lifecycle. This role offers unparalleled opportunities to shape medical advancements while collaborating with top-tier physicians and scientists in our state-of-the-art facilities.
Responsibilities
- Oversee protocol implementation, ensuring adherence to FDA regulations and ICH-GCP standards
- Manage subject recruitment, screening, and enrollment processes across clinical sites
- Coordinate data collection, verification, and maintenance in electronic health records (EHRs)
- Liaise with regulatory bodies, ethics committees, and pharmaceutical sponsors
- Train clinical staff on study procedures and documentation requirements
- Monitor trial progress, identify risks, and implement corrective actions
- Prepare regulatory submissions and audit documentation
Qualifications
- Bachelor's degree in Life Sciences, Nursing, or related field (Master's preferred)
- 3+ years clinical trial coordination experience in oncology or rare diseases
- Certified Clinical Research Professional (CCRP) certification required
- Expertise in EHR systems (e.g., Epic, Medidata Rave)
- Strong knowledge of FDA 21 CFR Part 11 and ICH-GCP guidelines
- Exceptional attention to detail and documentation skills
- Experience with multi-site trial coordination and vendor management
- Proven ability to manage complex timelines and competing priorities