Job Description
Join BioVita Therapeutics, a leader in innovative pharmaceutical research, as we pioneer next-generation therapies. We seek a highly motivated Senior Clinical Research Associate to drive our clinical trials from concept to completion. This role offers the opportunity to work with cutting-edge science while ensuring regulatory compliance and data integrity in a dynamic, collaborative environment.
As a key member of our Clinical Operations team, you'll orchestrate complex multi-site trials, mentor junior staff, and contribute to strategic trial design. Our Boston headquarters provides state-of-the-art facilities and proximity to world-class research institutions, fostering unparalleled professional growth.
Responsibilities
- Lead clinical trial execution across multiple sites, ensuring adherence to protocols, GCP, and FDA regulations
- Monitor site performance through regular visits and audits, identifying and resolving protocol deviations
- Oversee data management processes, including source data verification and CRF review
- Develop and maintain strong relationships with investigators, sponsors, and CRO partners
- Contribute to clinical study protocol development and operational planning
- Mentor junior CRAs and provide training on SOPs and regulatory requirements
- Prepare comprehensive study reports and regulatory submissions
Qualifications
- Bachelor's degree in life sciences, nursing, or related field (Master's preferred)
- 5+ years of clinical research experience with 2+ years in a CRA role
- Certified Clinical Research Associate (CCRA) or equivalent certification
- Deep expertise in FDA regulations, ICH-GCP, and clinical trial methodologies
- Proven track record in managing complex multi-site oncology trials
- Exceptional communication and problem-solving abilities
- Proficiency in EDC systems (e.g., Medidata Rave) and TMF management