Job Description

• This role is designed to be 100% onsite, giving you the opportunity to collaborate closely with your team and immerse yourself in the energy of our workplace.
• Please note that hybrid or remote work options are NOT available for this position at this time

• High School Diploma/GED required. Bachelor's degree preferred.
• 1 year Clinical research related experience required.
• Chemo, Oncology, or pharmaceutical research experience

• Submits research projects (protocols, consent forms, recruitment materials, IRB application, etc.) for human subjects' approval.
• Submits appropriate internal documentation for contract execution. Maintains communication with contracting officers and sponsors of research during the budgeting and negotiating process.
• Develops research project budgets based on protocol requirements and Cedars-Sinai published research costs, ensuring that all anticipated costs are appropriately accommodated and that research protocol, research budget and research subject informed consent documents are consistent.
• Monitors study payments and generates invoices as necessary to ensure adequate funding throughout the course of the trial.
• Ensures timely filing of annual renewals and amendment submissions to IRB.
• Ensures the completion and maintenance of consent forms, case report forms, SAE's and source documents to ensure that research is being conducted according to IRB, FDA, OHRP, HIPAA and other agency guidelines.
• Maintains high quality, up-to-date regulatory files (CITI and other training documents, financial disclosures, FDA forms, CVs, medical licenses, etc.) for research studies.
• Completes appropriate IRB paperwork and submits internal and external Serious Adverse Events (SAEs) and INDSRs to IRB.
• May help coordinate and prepare for institutional, pharmaceutical and internal audits.
• Coordinates site feasibility visits and site initiation visits for potential studies. Completes feasibility questionnaires.
• Provides facility tours to visiting research sponsors, CROs, and other personnel for research-related activities.
• Coordinates and collaborates with internal and external investigators and participating centers in multi-center studies to achieve research goals.
• Participates in weekly research staff meetings.
• Protects rights and research data of research volunteers, including medical records, data, etc. Obtains necessary consent forms, or HIPAA information forms as needed, in research process.
• Performs administrative duties in a timely manner as assigned.

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