Job Description
Join Boston Medical Innovations as a Clinical Research Coordinator and drive groundbreaking medical advancements. We're seeking a passionate professional to orchestrate pivotal clinical trials, ensuring regulatory compliance and patient safety while accelerating life-changing therapies to market.
Our state-of-the-art research center in Boston's Longwood Medical Area offers collaborative environments with Harvard-affiliated institutions, cutting-edge technology, and competitive benefits. This hybrid role blends hands-on patient interaction with data-driven innovation.
Responsibilities
- Design and implement clinical trial protocols in compliance with FDA/ICH-GCP standards
- Recruit, screen, and enroll study participants while maintaining ethical oversight
- Manage electronic data capture systems and ensure data integrity
- Coordinate multidisciplinary teams including physicians, statisticians, and regulatory affairs
- Prepare regulatory submissions and maintain audit-ready documentation
- Monitor adverse events and ensure patient safety protocols are followed
- Analyze trial data and prepare comprehensive reports for sponsors
Qualifications
- Bachelor's degree in Life Sciences, Nursing, or related field (Master's preferred)
- 3+ years clinical research coordination experience with oncology trials
- Certified Clinical Research Professional (CCRP) or ACRP certification
- Proficiency in clinical trial management systems (e.g., Medidata Rave, Veeva Vault)
- Strong knowledge of FDA 21 CFR Part 11 and HIPAA regulations
- Exceptional communication skills for patient interactions and stakeholder management
- Experience managing complex multi-center trials and budget oversight
- Ability to thrive in fast-paced environments with competing priorities