Senior Principal Biostatistician providing statistical expertise across therapeutic areas in clinical development. Collaborating with study teams and overseeing analysis plans for vital projects.
About the role
- Clinical Research Coordinator supporting clinical research for pediatric care at Shriners Children’s. Ensuring compliance with research protocols and collaborating with clinical teams in Pasadena.
Responsibilities
- Supports the implementation and conduct of approved research protocols, ensuring studies are performed in compliance with the protocol, Good Clinical Practice (GCP), applicable regulatory requirements, and SHC policies and standards.
- Performs study-specific research activities and/or interventions within the bounds of professional licensure and training.
- Assists with participant recruitment, screening, informed consent/assent, scheduling, and coordination of study visits.
- Coordinates the collection and documentation of research data.
- Maintains regulatory documentation and study records in accordance with institutional policies and sponsor requirements.
- Supports communication and coordination between investigators, sponsors, monitors, and institutional departments involved in research activities.
- Assists investigators with the development and submission of investigator-initiated research protocols and related regulatory documentation.
- Contributes to study progress reports, monitoring visits, audits, and preparation of study results or presentations when applicable.
- Ensures appropriate training and education are completed in order to safely perform study-related procedures and protocol requirements.
Requirements
- Bachelor’s degree in Clinical Research, Life Sciences, Public Health, or another healthcare-related field
- Working knowledge of regulations and guidance related to clinical research (e.g., GCP, FDA regulations, IRB requirements)
- Experience coordinating intergroup or multi-site clinical studies
- CCRP or CCRC certification
- 1 or more years of relevant research experience (e.g., study coordination, site management, regulatory submissions, or clinical data management)
Benefits
- Medical coverage on the first day
- 403(b) and Roth 403(b) Retirement Saving Plan with matching contributions of up to 6% after one year of service
- Paid time off
- Life insurance
- Short term and long-term disability
- Flexible Spending Account (FSA) plans
- Health Savings Account (HSA) if a High Deductible Health Plan (HDHP) is elected
- Tuition reimbursement
- Home & auto insurance
- Hospitalization insurance
- Critical illness insurance
- Pet insurance
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