Job Description
Join Boston Medical Innovations at the forefront of groundbreaking clinical research. We're seeking a meticulous Senior Clinical Research Coordinator to lead pivotal studies that transform patient care. Our state-of-the-art facility in Boston's Innovation District offers unparalleled resources to accelerate medical breakthroughs. You'll collaborate with world-class physicians, scientists, and regulatory experts in a dynamic environment where your expertise directly impacts global health outcomes.
Why Choose Us? We offer competitive benefits, continuous professional development, and a culture that values innovation and patient-centric solutions. Be part of a team where your work saves lives and shapes the future of medicine.
Responsibilities
- Design, implement, and monitor clinical trials ensuring strict adherence to FDA regulations and GCP standards
- Coordinate multidisciplinary teams including investigators, sponsors, and regulatory bodies
- Manage complex data collection, analysis, and reporting using EDC systems (e.g., Medidata Rave)
- Oversee patient recruitment strategies, informed consent processes, and ethical protocol compliance
- Lead site initiation visits, audits, and regulatory submissions for Phase II-III trials
- Maintain meticulous trial documentation and prepare FDA/EMA submissions
- Present findings at scientific conferences and contribute to peer-reviewed publications
Qualifications
- Master's degree in Clinical Research, Nursing, Life Sciences, or related field
- 5+ years of clinical research coordination experience in Phase II-III trials
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven expertise with EDC systems and regulatory documentation (21 CFR Part 11)
- Strong knowledge of ICH-GCP, FDA, and international regulatory requirements
- Exceptional organizational skills with ability to manage complex timelines and budgets
- Experience in therapeutic areas (Oncology, Cardiology, or Neurology preferred)
- Excellent communication skills for stakeholder management and patient engagement