Job Description
Join BioPharm Innovations Inc., a leader in groundbreaking oncology therapies, as we accelerate the development of life-changing treatments. We're seeking a meticulous Senior Clinical Research Associate to oversee complex clinical trials across the Northeast region. This hybrid role offers the opportunity to shape regulatory strategy while collaborating with world-class scientists and medical professionals. Enjoy competitive compensation, comprehensive benefits, and a culture that values innovation and work-life balance.
Responsibilities
- Design and implement clinical trial protocols in compliance with FDA/ICH-GCP regulations
- Monitor investigational sites for protocol adherence, data integrity, and regulatory compliance
- Lead vendor management and site selection for multi-center oncology trials
- Analyze clinical data and prepare comprehensive study reports for regulatory submissions
- Collaborate with cross-functional teams (medical, regulatory, biostatistics) to ensure trial milestones
- Train and mentor junior CRAs on SOPs and clinical trial conduct
- Manage clinical trial budgets and vendor contracts
Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, or related field (Master's preferred)
- 5+ years of clinical research experience with Phase II-III oncology trials
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven expertise in FDA/ICH-GCP and clinical trial regulations
- Advanced proficiency in eCRF systems (Medidata Rave, Veeva Vault)
- Exceptional problem-solving skills and attention to detail
- Strong leadership abilities with experience mentoring CRAs
- Valid driver's license and willingness to travel (30% domestic)