Job Description
Shape the Future of Medicine at BioVita Therapeutics
We're pioneering breakthrough therapies in oncology and immunology, and we need exceptional talent to accelerate our clinical trials. As a Senior Clinical Research Associate, you'll drive our mission to deliver life-changing treatments to patients worldwide. Join our collaborative team where innovation meets compassion.
Responsibilities
- Oversee Phase I-III clinical trials ensuring protocol adherence and regulatory compliance (ICH-GCP, FDA)
- Monitor investigational sites through on-site visits and remote audits to maintain data integrity
- Lead site selection, initiation, and closure activities across multi-center studies
- Collaborate with cross-functional teams (medical, regulatory, biostatistics) to resolve operational issues
- Develop and maintain study documentation (CRFs, IBs, SOPs) with meticulous attention to detail
- Analyze clinical data trends and prepare comprehensive reports for FDA submissions
Qualifications
- Master's degree in Life Sciences, Pharmacy, or related field (PhD preferred)
- 5+ years of clinical research experience with 2+ years in CRA role
- Certified Clinical Research Associate (ACRP or SOCRA) required
- Proven expertise in oncology/immunology therapeutic areas
- Advanced proficiency in EDC systems (Medidata Rave) and risk-based monitoring
- Exceptional communication skills for stakeholder management
- Valid driver's license for travel (up to 40% nationally)