Job Description
Join BioVita Therapeutics, a leader in innovative pharmaceutical solutions, as a Senior Clinical Research Associate. You'll drive critical clinical trials from protocol design to final reporting, ensuring compliance with global regulatory standards. Collaborate with cross-functional teams to advance life-changing therapies while maintaining data integrity and patient safety. We offer a dynamic environment with cutting-edge resources and career growth opportunities.
Responsibilities
- Design and execute clinical trial protocols in compliance with GCP and FDA regulations
- Monitor investigational sites to ensure protocol adherence and data quality
- Manage site relationships, training, and regulatory documentation
- Analyze clinical data and prepare comprehensive study reports
- Coordinate with CROs, vendors, and internal stakeholders
- Lead risk-based monitoring strategies and ensure audit readiness
Qualifications
- Bachelor's degree in life sciences, pharmacy, or related field (Master's preferred)
- 5+ years of clinical research experience in pharmaceutical/biotech
- CRA certification (ACRP or SOCRA) required
- Proven expertise in oncology or rare disease trials
- Strong knowledge of ICH-GCP, FDA, and EMA regulations
- Excellent data management and audit skills
- Exceptional communication and problem-solving abilities