Job Description
Join our elite research team at Precision Health Solutions, where innovation meets compassionate care. We're seeking a meticulous Senior Clinical Research Coordinator to drive groundbreaking trials in oncology and immunology. This hybrid role offers competitive compensation, comprehensive benefits, and the opportunity to shape the future of precision medicine. Collaborate with world-renowned physicians and leverage cutting-edge technology to accelerate therapeutic discoveries. If you're passionate about transforming patient outcomes through rigorous clinical science, this is your next career-defining move.
Responsibilities
- Oversee complex multi-center clinical trials from protocol development to final FDA submission
- Manage regulatory documentation ensuring 100% compliance with FDA, ICH-GCP, and HIPAA standards
- Lead investigator meetings and train 5+ junior coordinators on SOPs and study protocols
- Analyze clinical data using SAS and R to generate actionable insights for biostatistical teams
- Coordinate site initiation, monitoring, and closeout activities across 15+ international sites
- Develop patient recruitment strategies achieving 120% of enrollment targets
- Prepare FDA submissions and maintain audit-ready electronic trial master files
Qualifications
- Master's degree in Clinical Research, Nursing, or Life Sciences with 5+ years' CRC experience
- Certified Clinical Research Professional (CCRP) or equivalent certification required
- Proven expertise in oncology/immunology trials with Phase I-III experience
- Advanced proficiency in EDC systems (Medidata Rave) and CTMS software
- Exceptional audit readiness with zero 483 observations in past 3 audits
- Strong budget management experience for trials exceeding $5M
- Fluency in regulatory documentation (IB, ICF, CRFs, AE reports)
- Experience managing international site coordination across 3+ countries