Job Description
Join BioInnovate Pharmaceuticals as a Senior Clinical Research Associate and drive groundbreaking therapies to market! We're seeking a meticulous professional to oversee clinical trials ensuring FDA/GMP compliance while collaborating with cross-functional teams. Enjoy a competitive salary, comprehensive benefits package, and opportunities to shape the future of medicine in our state-of-the-art Boston facility.
Responsibilities
- Monitor clinical trial sites for protocol adherence and data integrity
- Conduct site visits, audits, and vendor management
- Ensure compliance with ICH-GCP and FDA regulations
- Collaborate with medical teams on adverse event reporting
- Maintain electronic trial master files and documentation
- Liaise between sponsors, investigators, and regulatory bodies
- Mentor junior CRAs on SOPs and best practices
Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, or related field
- 5+ years of clinical research experience in pharma/biotech
- CRA certification (ACRP/SoCRA preferred)
- Proven expertise in Phase II-III trials and FDA inspections
- Strong knowledge of EDC systems (e.g., Medidata Rave)
- Exceptional problem-solving and communication skills
- Ability to travel up to 40% domestically