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Cedars-Sinai · 2 months ago

Research Associate II - The Angeles Clinic & Research Institute

11800 Wilshire Blvd, Los Angeles, CA, 90025, US

Full-time

Onsite

Mid Level

$22.35/hr - $34.64/hr

Cedars-Sinai is a renowned healthcare institution known for its commitment to innovative cancer care and research. The Research Associate II plays a crucial role in managing regulatory documents and ensuring compliance with research protocols while supporting the administrative aspects of clinical trials.

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

Regulatory document managementBudget developmentIRB submissionResearch project coordinationCommunication skillsTeam collaborationAttention to detail

Required

High level of excellence and commitment to perform a wide variety of activities integral to the successful management and administration of essential regulatory documents

Ensures timely submission of complete, accurate and current documents to research sponsors, IRBs, and contract research organizations

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

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

Maintains high quality, up-to-date regulatory files 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

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

Benefits

Outstanding benefits package

Company

Cedars-Sinai

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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