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Cedars-Sinai · 3 days ago

Research Associate II - The Angeles Clinic & Research Institute

Los Angeles, CA

Full-time

Onsite

Entry Level

$24/hr - $34.64/hr

1+ years exp

Cedars-Sinai is a leading healthcare institution known for its innovative cancer therapies and commitment to patient care. The Research Associate II plays a critical role in managing regulatory documents and ensuring compliance for research projects, contributing to the advancement of cancer research and treatment.

CommunitiesHealth CareMedicalNon Profit

Comp. & Benefits

Responsibilities

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

Qualification

Clinical research experienceRegulatory document managementIRB submissionBudget developmentCollaboration with investigators

Required

High School Diploma/GED required

1 year Clinical research related experience required

Preferred

Bachelor's degree preferred

Benefits

Outstanding benefits package

Competitive salaries

Company

Cedars-Sinai

Glassdoor4.0

Since its beginning in 1902, Cedars-Sinai has evolved to meet the healthcare needs of one of the most diverse regions in the nation, continually setting new standards for quality and innovation in patient care, research, teaching and community service.

Founded in 1902

Los Angeles, California, USA

10001+ employees