Job Description
Join BioPharm Innovations LLC, a leader in cutting-edge pharmaceutical research, as we pioneer breakthrough therapies to transform global healthcare. Our Princeton-based team is seeking a dedicated Senior Clinical Research Associate to drive excellence in clinical trials. You'll collaborate with cross-functional teams to ensure compliance with FDA regulations and GCP standards while advancing life-changing treatments. Enjoy competitive benefits, professional development opportunities, and the chance to make a tangible impact on patient outcomes.
Responsibilities
- Design, implement, and monitor Phase I-IV clinical trials ensuring adherence to protocols and regulatory requirements
- Conduct site visits, audits, and source data verification to maintain trial integrity
- Liaise with investigators, sponsors, and ethics committees to resolve protocol deviations and ensure timely study execution
- Analyze clinical data, prepare study reports, and contribute to regulatory submissions
- Maintain electronic trial master files and ensure complete documentation in compliance with 21 CFR Part 11
- Mentor junior CRAs and contribute to process improvement initiatives
Qualifications
- Bachelor's degree in life sciences, pharmacy, or related field (Master's preferred)
- Minimum 5 years of clinical research experience with 2+ years in CRA role
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven expertise in FDA regulations, ICH-GCP, and clinical trial methodologies
- Exceptional data management and auditing skills with electronic systems (e.g., Medidata Rave)
- Strong communication abilities for stakeholder management and conflict resolution
- Experience in oncology or rare disease trials highly desirable