Job Description
Join BioVance Therapeutics, a leader in innovative pharmaceutical solutions, as we pioneer breakthrough treatments for rare diseases. We seek a dynamic Senior Clinical Research Associate to drive our Phase II-III trials from protocol to approval. You'll collaborate with cross-functional teams to ensure regulatory compliance, patient safety, and data integrity while shaping the future of precision medicine. Enjoy competitive benefits, flexible work arrangements, and opportunities to present at global industry conferences.
Responsibilities
- Lead site initiation, monitoring, and closure for multi-center clinical trials
- Conduct GCP-compliant audits and ensure protocol adherence across 15+ sites
- Manage electronic data capture (EDC) systems and resolve data discrepancies
- Prepare regulatory submissions (IND/CTA) and FDA correspondence
- Mentor junior CRAs and optimize clinical trial workflows
- Collaborate with biostatisticians on endpoint analysis and safety reporting
Qualifications
- Bachelor's degree in Pharmacy, Nursing, or Life Sciences; advanced degree preferred
- 5+ years of clinical research experience with 3+ years in CRA role
- ICH-GCP and FDA 21 CFR Part 11 certification
- Expertise in oncology/neurology therapeutic areas
- Proven ability to manage complex trial budgets and timelines
- Strong proficiency in Medidata Rave or equivalent EDC platforms
- Certified Clinical Research Professional (CCRP) designation