Job Description
Join BioVita Innovations, a leader in pioneering pharmaceutical breakthroughs, as we revolutionize patient care through cutting-edge clinical trials. We seek a dynamic Senior Clinical Research Associate to spearhead complex clinical studies across multiple therapeutic areas. In this pivotal role, you'll collaborate with cross-functional teams to ensure protocol compliance, data integrity, and regulatory adherence while driving innovation in drug development. Enjoy a collaborative environment with competitive benefits, professional development opportunities, and the chance to impact global healthcare.
Responsibilities
- Design, implement, and monitor Phase II-III clinical trials ensuring GCP compliance and protocol integrity
- Lead site initiation, monitoring, and closeout activities across 8-10 investigational sites
- Collaborate with medical, regulatory, and data teams to resolve protocol deviations and data queries
- Analyze clinical data and prepare comprehensive study reports for FDA submissions
- Mentor junior CRAs and contribute to process optimization initiatives
- Conduct vendor management and budget oversight for assigned studies
Qualifications
- Bachelor's degree in Pharmacy, Nursing, Life Sciences, or related field (Master's preferred)
- 5+ years of clinical research experience with 2+ years in CRA or equivalent role
- Certified CRA (CCRA) or equivalent certification required
- Proven expertise in oncology or rare disease therapeutic areas
- Advanced knowledge of FDA regulations, ICH-GCP, and clinical trial protocols
- Exceptional data management and audit trail review capabilities
- Strong leadership skills with experience managing cross-functional teams