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Research Associate II
2 months ago
Cedars-Sinai is seeking a highly skilled Research Associate II to join our team in the Angeles Research Institute. This role will be responsible for ensuring the timely submission of regulatory documents to research sponsors, IRBs, and contract research organizations.
Key Responsibilities:
- Submit research projects for human subjects' approval, ensuring compliance with regulatory guidelines.
- Coordinate with contracting officers and sponsors to negotiate and execute contracts.
- Monitor study payments and generate invoices to ensure adequate funding.
- Ensure timely filing of annual renewals and amendment submissions to IRBs.
- Maintain high-quality regulatory files, including training documents, financial disclosures, and FDA forms.
- Complete IRB paperwork and submit internal and external Serious Adverse Events (SAEs) and INDSRs.
- Coordinate site feasibility visits and site initiation visits for potential studies.
- Provide facility tours to visiting research sponsors and personnel.
- Collaborate with internal and external investigators to achieve research goals.
- Participate in weekly research staff meetings.
- Protect research data and obtain necessary consent forms and HIPAA information.
- Perform administrative duties as assigned.
Requirements:
- High School Diploma/GED required.
- BS/BA degree in a scientific or healthcare field preferred.
- 1 year of clinical research or relevant experience.