Job Description
Join Precision Health Partners at the forefront of medical innovation! We're seeking a Senior Clinical Research Coordinator to lead groundbreaking studies in oncology therapeutics. This pivotal role combines scientific rigor with compassionate patient care in our state-of-the-art research facility.
As a key member of our clinical trials team, you'll orchestrate complex multi-center studies while mentoring junior coordinators. Our dynamic environment offers unparalleled opportunities for professional growth and direct impact on patient outcomes.
Responsibilities
- Design and execute Phase I-III oncology clinical trials with 15+ active protocols
- Manage FDA compliance, IRB submissions, and regulatory documentation
- Lead cross-functional teams of physicians, data managers, and biostatisticians
- Implement EDC systems for real-time data monitoring and quality assurance
- Coordinate investigator meetings and prepare FDA audit-ready documentation
- Mentor 3 junior coordinators on GCP standards and SOPs
- Develop patient recruitment strategies exceeding 85% target enrollment
Qualifications
- Master's degree in Clinical Research, Nursing, or related life science field
- 5+ years of oncology clinical trial coordination experience
- Certified Clinical Research Professional (CCRP) required
- Expertise in Oncology CTC AE v5.0 and MedDRA coding systems
- Advanced proficiency in Oracle Clinical and Rave EDC platforms
- Proven track record with FDA 483 responses and corrective/preventive actions
- Strong experience with site initiation visits and monitoring visits
- Excellent written communication skills for protocol development and reporting