Job Description
Join BioNovate Therapeutics as a Senior Clinical Research Associate and lead pivotal clinical trials that transform patient lives. We're pioneering next-generation therapies in oncology and rare diseases, and we need your expertise to ensure regulatory excellence and data integrity. In this role, you'll collaborate with cross-functional teams to drive trial execution from protocol design to final report, while mentoring junior CRAs and optimizing processes. Our Cambridge headquarters offers state-of-the-art labs and a culture where innovation meets impact.
We provide comprehensive benefits including premium health insurance, 401(k) matching, and continuing education stipends. If you're passionate about accelerating drug development and thrive in dynamic environments, apply now to shape the future of medicine.
Responsibilities
- Oversee clinical trial execution across 5-8 sites, ensuring protocol adherence and GCP compliance
- Conduct comprehensive site monitoring visits, including initiation, interim, and close-out phases
- Manage electronic data capture (EDC) systems and resolve data discrepancies within SLAs
- Lead investigator meetings and provide training on trial protocols and regulatory requirements
- Develop and maintain study documentation, including informed consent forms and regulatory submissions
- Analyze safety data and prepare pharmacovigilance reports for regulatory authorities
- Mentor junior CRAs and contribute to process improvement initiatives
Qualifications
- Bachelor's degree in life sciences, nursing, or clinical research; Master's preferred
- 5+ years of clinical research experience with 2+ in CRA roles
- Certification in clinical research (ACRP or SOCRA) required
- Proven expertise in ICH-GCP, FDA, and EMA regulations
- Advanced proficiency in EDC systems (e.g., Medidata Rave, Veeva Vault)
- Exceptional communication skills for cross-functional collaboration
- Ability to travel 30-40% domestically and internationally
- Experience in oncology or rare disease trials highly valued