Job Description
Join BioNova Therapeutics, a leader in innovative pharmaceutical solutions, as we pioneer groundbreaking therapies for rare diseases. We seek a meticulous Senior Clinical Research Associate to drive our clinical trials from protocol to completion. In this pivotal role, you'll collaborate with cross-functional teams to ensure regulatory compliance, data integrity, and patient safety while advancing life-changing treatments. Enjoy competitive compensation, comprehensive benefits, and opportunities for professional growth in a dynamic, science-driven environment.
Responsibilities
- Oversee site initiation, monitoring, and closure for Phase I-III clinical trials
- Ensure protocol adherence and compliance with GCP/ICH guidelines
- Manage clinical documentation, including CRFs and regulatory submissions
- Conduct risk-based monitoring and vendor oversight
- Lead study start-up activities and site training programs
- Collaborate with Data Management to ensure data quality and timelines
- Represent BioNova at regulatory audits and inspections
Qualifications
- Bachelor's degree in life sciences, pharmacy, or related field (Master's preferred)
- 5+ years of clinical research experience in pharmaceutical/biotech
- Certified Clinical Research Associate (CCRA) or equivalent certification
- Proven expertise in FDA/EMA regulations and GCP principles
- Strong project management and vendor management skills
- Exceptional attention to detail and documentation accuracy
- Experience with EDC systems (e.g., Medidata Rave) and CTMS platforms