Job Description
Join Boston Medical Innovations as a Clinical Research Coordinator and play a pivotal role in advancing medical breakthroughs. We're seeking a meticulous professional to manage complex clinical trials, ensuring compliance with FDA regulations and ethical standards. You'll collaborate with multidisciplinary teams to drive life-saving research from conception to completion.
Our state-of-the-art research facility in Boston's Medical District offers an environment where innovation meets integrity. Enjoy competitive benefits, professional development opportunities, and the chance to impact global healthcare outcomes.
Responsibilities
- Coordinate and monitor clinical trial protocols, ensuring adherence to GCP and regulatory standards
- Recruit, screen, and enroll study participants while maintaining ethical documentation
- Manage trial documentation, including informed consent forms and case report forms
- Liaise with investigators, sponsors, and regulatory bodies to ensure protocol compliance
- Analyze and report trial data, preparing comprehensive study reports
- Train clinical staff on study procedures and regulatory requirements
- Oversee trial budgets and vendor relationships
Qualifications
- Bachelor's degree in Nursing, Life Sciences, or related field (Master's preferred)
- 2+ years clinical research coordination experience with FDA-regulated trials
- Certified Clinical Research Professional (CCRP) certification required
- Proficiency in electronic data capture systems (e.g., Medidata Rave)
- Deep knowledge of ICH-GCP guidelines and FDA regulations
- Exceptional organizational skills with attention to detail
- Strong communication abilities for stakeholder management
- Ability to work independently in a fast-paced environment