Job Description
Join BioPharm Innovations at the forefront of medical breakthroughs as a Senior Clinical Research Associate. We're seeking a dedicated professional to oversee pivotal clinical trials, ensuring regulatory compliance and data integrity while advancing life-changing therapies. Work in our state-of-the-art Boston facility alongside world-class researchers to accelerate drug development from lab to market. Enjoy competitive compensation, comprehensive benefits, and opportunities for professional growth in a dynamic pharmaceutical environment.
Responsibilities
- Design, implement, and monitor Phase I-IV clinical trials in compliance with FDA/ICH-GCP standards
- Serve as primary liaison between investigative sites, sponsors, and internal stakeholders
- Conduct site initiation, monitoring, and closeout visits with 95% protocol adherence
- Analyze clinical data to identify trends, risks, and opportunities for optimization
- Develop and maintain comprehensive study documentation (eCRFs, IBs, SOPs)
- Collaborate with cross-functional teams (Biostatistics, Medical Affairs, Regulatory)
- Mentor junior CRAs and contribute to process improvement initiatives
Qualifications
- Bachelor's degree in life sciences, nursing, or related field (Master's preferred)
- 5+ years clinical research experience with 2+ years in CRA role
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Deep knowledge of FDA/ICH-GCP, FDA regulations, and clinical trial methodologies
- Proven expertise in EDC systems (e.g., Medidata Rave, Veeva Vault)
- Exceptional data management and risk-based monitoring skills
- Strong written/verbal communication and stakeholder management abilities