Job Description
Join BioVita Therapeutics, a leader in innovative pharmaceutical research, as we pioneer breakthrough therapies in oncology and immunology. We're seeking a passionate Senior Clinical Research Associate to lead complex clinical trials and ensure regulatory compliance while driving medical innovation forward. This hybrid role offers the opportunity to shape the future of healthcare with cutting-edge science.
Our Cambridge campus features state-of-the-art laboratories and collaborative spaces where your expertise will directly impact patient outcomes. Enjoy comprehensive benefits including equity participation, continuing education stipends, and flexible work arrangements.
Responsibilities
- Design, implement, and oversee Phase II-III clinical trials across multiple therapeutic areas
- Monitor investigational sites for protocol adherence, GCP compliance, and data integrity
- Lead vendor management and budget oversight for assigned clinical trials
- Coordinate cross-functional teams including medical, regulatory, and biostatistics
- Develop and maintain risk-based monitoring strategies and site management plans
- Conduct internal audits and ensure FDA/ICH regulatory compliance
- Mentor junior CRAs and contribute to process improvement initiatives
Qualifications
- Master's degree in Life Sciences, Pharmacy, or related field with 5+ years clinical research experience
- Certified Clinical Research Professional (CCRP) or equivalent certification required
- Demonstrated expertise in oncology and/or immunology clinical trials
- Strong knowledge of ICH-GCP, FDA regulations, and clinical trial methodologies
- Exceptional project management skills with multi-site trial experience
- Advanced proficiency in eCRF systems (e.g., Medidata Rave, Veeva Vault)
- Excellent communication skills with proven stakeholder management abilities