Job Description
Join BioPharm Innovations Inc., a leader in groundbreaking pharmaceutical research, as we pioneer the next generation of life-changing therapies. We seek a dynamic Senior Clinical Research Associate to lead critical trials in our Boston facility. You'll collaborate with cross-functional teams to ensure regulatory compliance, data integrity, and patient safety throughout the clinical trial lifecycle. This role offers competitive compensation, comprehensive benefits, and opportunities to advance your career in a cutting-edge environment.
Responsibilities
- Design, implement, and monitor Phase I-III clinical trials ensuring adherence to GCP/ICH guidelines
- Lead site initiation, monitoring, and closure activities with 15+ investigational sites
- Manage clinical data collection, analysis, and reporting using EDC systems (e.g., Medidata Rave)
- Develop and maintain comprehensive trial protocols, informed consent forms, and regulatory documents
- Collaborate with medical monitors and biostatisticians to resolve protocol deviations and safety concerns
- Mentor junior CRAs and contribute to process improvement initiatives
Qualifications
- Bachelor's degree in life sciences, pharmacy, or related field (Master's preferred)
- 5+ years of clinical research experience with 2+ years in CRA role
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven expertise in FDA/EMA regulatory compliance and GCP standards
- Advanced proficiency in EDC systems and clinical trial management software
- Exceptional communication skills for stakeholder management across global sites
- Experience with oncology or rare disease trials highly desirable