Job Description
Join BioVance Therapeutics, a pioneering biopharmaceutical company dedicated to transforming patient outcomes through innovative therapies. We seek a passionate Senior Clinical Research Associate to drive excellence in clinical trial execution and regulatory compliance. Be part of a collaborative team that's accelerating breakthrough treatments while upholding the highest ethical standards. Enjoy competitive benefits, flexible work arrangements, and opportunities for professional growth in Boston's thriving life sciences ecosystem.
Responsibilities
- Design, implement, and monitor Phase I-III clinical trials ensuring protocol adherence and data integrity
- Liaise with investigative sites, sponsors, and regulatory agencies (FDA, EMA) to ensure compliance with GCP and ICH guidelines
- Conduct site initiation, monitoring, and closeout visits with comprehensive source data verification
- Analyze clinical data, prepare regulatory submissions, and contribute to safety reporting and risk management
- Mentor junior CRAs and contribute to process improvements in clinical operations
Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, or related field (Master's preferred)
- Minimum 5 years of clinical research experience with 2+ in CRA roles
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven expertise in oncology or rare disease therapeutic areas
- Strong knowledge of FDA/EMA regulations and clinical trial methodologies
- Exceptional problem-solving skills and attention to detail
- Valid driver's license and willingness to travel up to 30%