Job Description
Join BioVita Therapeutics, a leader in innovative drug development, as a Senior Clinical Research Associate. Shape the future of medicine by managing pivotal clinical trials that bring breakthrough therapies to patients worldwide. Our Boston hub offers a collaborative environment where scientific excellence meets industry impact.
This role is ideal for a proactive professional passionate about accelerating pharmaceutical innovation. You'll ensure protocol integrity, drive regulatory compliance, and mentor cross-functional teams while working on cutting-edge therapies in oncology and rare diseases.
BioVita offers competitive compensation, flexible work arrangements, and robust professional development programs. Join us in transforming patient outcomes through rigorous clinical research excellence.
Responsibilities
- Oversee clinical trial execution across multiple sites, ensuring protocol adherence and GCP compliance
- Conduct site monitoring visits, source data verification, and risk-based quality management
- Lead regulatory submissions and FDA/EMA interactions for assigned studies
- Mentor junior CRAs and optimize clinical trial processes through continuous improvement initiatives
- Collaborate with biostatisticians, data managers, and medical monitors for integrated trial oversight
- Develop and maintain strong relationships with investigative sites and key opinion leaders
- Manage study budgets, timelines, and resource allocation for assigned therapeutic areas
Qualifications
- Bachelor's degree in life sciences, nursing, or related field; advanced degree preferred
- 5+ years of clinical research experience with 3+ years in CRA role
- Certified Clinical Research Associate (CCRA) or equivalent certification
- Deep expertise in ICH-GCP, FDA/EMA regulations, and clinical trial methodologies
- Proven track record in oncology or rare disease therapeutic areas
- Exceptional problem-solving skills and ability to navigate complex regulatory landscapes
- Strong proficiency in eCRF systems (e.g., Medidata Rave) and risk-based monitoring tools