Job Description
Join Boston Medical Innovations, a leader in cutting-edge medical research, as we revolutionize patient care through groundbreaking clinical trials. We're seeking a Clinical Research Coordinator to drive our mission of advancing medical science while ensuring the highest standards of patient safety and regulatory compliance. This hybrid role offers the opportunity to work with world-class physicians, innovative therapies, and diverse patient populations in Boston's vibrant healthcare ecosystem.
Our team operates at the intersection of medicine and technology, where your expertise will directly impact the development of life-changing treatments. We provide comprehensive training, competitive benefits, and a collaborative environment that values professional growth and work-life balance.
Responsibilities
- Oversee all aspects of clinical trial execution, including patient recruitment, informed consent processes, and protocol adherence
- Manage electronic data capture systems, ensuring accurate and timely documentation of study outcomes
- Coordinate with investigative sites, sponsors, and regulatory bodies to maintain compliance with FDA and GCP standards
- Conduct regular site monitoring visits and prepare detailed audit reports
- Maintain comprehensive regulatory documentation and ensure timely submission to ethics committees
- Collaborate with biostatisticians and medical writers to prepare interim and final study reports
- Train clinical staff on study protocols and regulatory requirements
Qualifications
- Bachelor's degree in Nursing, Pharmacy, or related healthcare field (Master's preferred)
- 3+ years of clinical research coordination experience with therapeutic trials
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proficiency in electronic data capture systems (e.g., Medidata Rave, Oracle Inform)
- Demonstrated knowledge of FDA regulations, ICH-GCP, and 21 CFR Part 11
- Exceptional organizational skills with ability to manage multiple concurrent studies
- Strong written and verbal communication skills for stakeholder interactions
- Experience with IRB submissions and regulatory document management