Job Description
Join Boston Medical Innovations as a Senior Clinical Research Coordinator and lead transformative clinical trials that shape the future of healthcare. We're seeking a dedicated professional to oversee complex medical research studies, ensuring compliance with FDA regulations and ethical standards. You'll collaborate with multidisciplinary teams including physicians, biostatisticians, and regulatory experts to drive innovative therapies from concept to patient impact. Our state-of-the-art facilities in Boston's renowned Longwood Medical Area provide an inspiring environment where your expertise will directly contribute to life-changing medical breakthroughs. Enjoy competitive compensation, comprehensive benefits, and opportunities for professional growth in a mission-driven organization.
Responsibilities
- Design and execute comprehensive clinical trial protocols adhering to ICH-GCP guidelines
- Manage site operations, including recruitment, patient monitoring, and data integrity
- Coordinate cross-functional teams (medical, regulatory, data management) for seamless trial execution
- Ensure compliance with FDA regulations, IRB protocols, and sponsor requirements
- Oversee adverse event reporting and risk management processes
- Analyze trial data and prepare regulatory submissions for FDA/EMA approval
- Mentor junior staff and implement continuous improvement initiatives
Qualifications
- Master's degree in Clinical Research, Nursing, Life Sciences, or related field
- 5+ years of clinical trial coordination experience in therapeutic areas (oncology/neurology preferred)
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven expertise in FDA 21 CFR Part 11 compliance and electronic data capture systems
- Exceptional project management skills with ability to manage complex timelines
- Strong understanding of biostatistical principles and clinical trial methodologies
- Excellent communication skills with ability to present findings to stakeholders
- Experience with site initiation, monitoring, and closeout processes