Job Description
Join NovoMed Therapeutics, a global leader in innovative drug development, as we pioneer next-generation treatments for rare diseases. We're seeking a passionate Senior Clinical Research Associate to lead critical trials that transform patient lives. In this pivotal role, you'll collaborate with cross-functional teams to ensure protocol compliance, data integrity, and regulatory excellence while advancing our mission to deliver breakthrough therapies.
Responsibilities
- Design and execute clinical trial protocols in compliance with FDA/ICH-GCP standards
- Monitor investigational sites to ensure protocol adherence and data quality
- Lead risk-based monitoring strategies and site management activities
- Coordinate cross-functional teams (medical, regulatory, biostatistics) for trial execution
- Conduct vendor management and site training initiatives
- Develop and maintain comprehensive trial documentation (CRFs, reports, SOPs)
Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, or related field (Master's preferred)
- 5+ years of clinical research experience with Phase I-III trials
- Certified Clinical Research Associate (CCRA) or equivalent certification
- Strong knowledge of FDA regulations, ICH-GCP, and clinical trial processes
- Exceptional communication skills for stakeholder management
- Experience with EDC systems (e.g., Medidata Rave) and risk-based monitoring
- Ability to travel up to 40% for site monitoring