Job Description
Join NovoBio Therapeutics as a Clinical Research Associate and drive innovation in pharmaceutical development. We're seeking a meticulous professional to oversee clinical trials from protocol design to regulatory submission. You'll collaborate with cross-functional teams to ensure compliance with FDA/ICH guidelines while advancing breakthrough therapies. This role offers hybrid work arrangements with competitive benefits and career growth opportunities in a cutting-edge research environment.
Responsibilities
- Design and execute clinical trial protocols ensuring regulatory compliance (GCP/ICH-GCP)
- Monitor trial sites for protocol adherence, data integrity, and patient safety
- Manage Investigative Site relationships and conduct on-site audits
- Analyze clinical data and prepare comprehensive study reports for regulatory submissions
- Coordinate with CROs, vendors, and internal stakeholders to meet project milestones
- Ensure timely submission of regulatory documents and adverse event reporting
Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, or related field (Master's preferred)
- 3+ years clinical research experience in pharmaceutical/biotech setting
- Certified Clinical Research Associate (CCRA) or equivalent certification
- Proficiency in EDC systems (e.g., Medidata Rave, Veeva Vault)
- Deep understanding of FDA 21 CFR Part 11 and ICH-GCP guidelines
- Exceptional attention to detail and documentation management skills
- Strong problem-solving abilities and cross-functional collaboration experience