Job Description
Join Boston Medical Innovations as a Senior Clinical Research Coordinator and lead transformative healthcare initiatives. We're seeking a passionate professional to drive cutting-edge clinical trials that directly impact patient outcomes. In this pivotal role, you'll collaborate with multidisciplinary teams to ensure regulatory compliance, protocol integrity, and seamless patient engagement. Our state-of-the-art research facility in Boston's medical district offers unparalleled resources for advancing medical science. If you thrive in dynamic environments where precision meets innovation, this is your opportunity to shape the future of healthcare.
Responsibilities
- Design and execute complex clinical trial protocols in compliance with FDA regulations and ICH-GCP standards
- Oversee site management, including recruitment, training, and performance monitoring of clinical staff
- Analyze and interpret biomedical data using advanced statistical software (SAS, R)
- Develop comprehensive informed consent documents and patient education materials
- Collaborate with biostatisticians and regulatory affairs to ensure data integrity
- Present findings at industry conferences and peer-reviewed publications
- Manage trial budgets and vendor relationships
Qualifications
- Master's degree in Clinical Research, Public Health, or related field
- 5+ years of clinical research coordination experience in oncology or cardiology
- Certified Clinical Research Professional (CCRP) certification
- Proficiency in electronic data capture systems (Medidata Rave, Veeva Vault)
- Expertise in FDA 21 CFR Part 11 compliance and risk-based monitoring
- Strong knowledge of HIPAA and patient privacy regulations
- Exceptional leadership skills with cross-functional team management experience
- Published research in peer-reviewed medical journals preferred