Job Description
Join BioVance Therapeutics, a leader in innovative pharmaceutical solutions, as a Senior Clinical Research Associate. You will play a pivotal role in advancing groundbreaking therapies through meticulous clinical trial oversight. Collaborate with cross-functional teams to ensure compliance with FDA regulations and GCP standards while driving patient-centered research initiatives. This position offers unparalleled growth in a dynamic biotech hub with competitive benefits and cutting-edge resources.
Responsibilities
- Oversee Phase I-III clinical trials, ensuring protocol adherence and data integrity
- Conduct site visits and monitor vendor compliance with regulatory requirements
- Lead regulatory submissions (IND/CTA) and maintain trial documentation
- Collaborate with medical teams to analyze safety data and adverse events
- Implement risk-based monitoring strategies for trial optimization
- Mentor junior CRAs and contribute to process improvements
Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, or related field (Master's preferred)
- 5+ years of clinical research experience with 2+ years in CRA roles
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven expertise in FDA regulations, ICH-GCP, and 21 CFR Part 820
- Strong data management and EDC system proficiency (e.g., Medidata Rave)
- Exceptional communication skills with cross-functional stakeholders
- Experience in oncology or rare disease trials highly desirable