Job Description
Join Boston Medical Innovations, a leader in cutting-edge medical research, as we pioneer breakthrough treatments for rare diseases. We're seeking a meticulous Clinical Research Coordinator to manage our clinical trials with precision and compassion. This pivotal role bridges scientific innovation and patient care in our state-of-the-art facilities. You'll collaborate with multidisciplinary teams to ensure regulatory compliance while transforming lives through medical advancement.
Responsibilities
- Oversee clinical trial protocols from initiation to closeout, ensuring FDA/ICH-GCP compliance
- Recruit, screen, and enroll participants while maintaining ethical standards
- Manage electronic data capture systems and maintain accurate regulatory documentation
- Coordinate with investigators, sponsors, and ethics committees for seamless trial execution
- Monitor adverse events and ensure patient safety protocols are rigorously followed
- Analyze trial data and prepare comprehensive reports for stakeholders
- Mentor junior staff on regulatory requirements and best practices
Qualifications
- Bachelor's degree in Nursing, Pharmacy, Life Sciences, or related field (Master's preferred)
- 3+ years of clinical research coordination experience in therapeutic areas
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proficiency in electronic data capture systems (e.g., Medidata Rave, Veeva)
- Demonstrated knowledge of FDA regulations, ICH-GCP, and 21 CFR Part 11
- Exceptional attention to detail and organizational skills
- Strong written communication for preparing protocols and regulatory submissions
- Ability to work effectively in cross-functional teams under tight deadlines