Job Description
Join Boston Medical Innovations as a Lead Clinical Research Coordinator and drive groundbreaking medical advancements in our state-of-the-art cardiovascular research division. We seek an experienced professional to oversee multi-phase clinical trials, ensuring compliance with FDA regulations and GCP standards. This pivotal role offers the opportunity to collaborate with top-tier physicians, lead cross-functional teams, and contribute to life-saving therapies.
Our team operates in a fast-paced, innovative environment where your expertise will directly impact patient outcomes. We offer competitive compensation, comprehensive benefits, and professional development opportunities in Boston's thriving medical ecosystem.
Responsibilities
- Design and implement clinical trial protocols in alignment with FDA regulations and GCP standards
- Manage site recruitment, patient enrollment, and data collection processes
- Oversee regulatory submissions, IRB approvals, and ethics compliance
- Coordinate cross-functional teams including physicians, nurses, and data managers
- Monitor trial progress, resolve protocol deviations, and ensure data integrity
- Prepare comprehensive trial reports and regulatory documentation
- Maintain electronic trial master files (eTMF) and audit readiness
Qualifications
- Bachelor's degree in Nursing, Life Sciences, or related field (Master's preferred)
- 5+ years of clinical research coordination experience with cardiovascular trials
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven expertise in FDA regulations, GCP, and ICH guidelines
- Advanced proficiency in electronic data capture systems (e.g., Medidata Rave)
- Strong leadership skills with experience managing multidisciplinary teams
- Exceptional attention to detail and problem-solving abilities
- Excellent written and verbal communication skills