Job Description
Join Boston Medical Innovations as a Clinical Research Coordinator and play a pivotal role in advancing groundbreaking medical treatments. We seek a meticulous professional to oversee clinical trials, ensuring compliance with FDA regulations and ethical standards. Collaborate with multidisciplinary teams to drive innovative therapies from concept to FDA approval. Enjoy competitive benefits, flexible scheduling, and opportunities for professional growth in a cutting-edge biotech environment.
Responsibilities
- Manage clinical trial protocols, ensuring adherence to GCP and ICH guidelines
- Recruit, screen, and enroll eligible study participants with precision
- Maintain accurate electronic and paper trial documentation
- Coordinate investigator meetings and regulatory submissions
- Analyze trial data and prepare comprehensive reports for stakeholders
- Liaise with ethics committees and regulatory bodies
- Mentor junior staff and conduct site audits
Qualifications
- Bachelor's degree in Nursing, Life Sciences, or related field (Master's preferred)
- 3+ years of clinical research coordination experience
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proficiency in EDC systems (e.g., Medidata Rave, Veeva Vault)
- Deep understanding of FDA 21 CFR Part 11 and ICH-GCP guidelines
- Exceptional organizational and communication skills
- Ability to manage competing priorities in a fast-paced environment