Cedars-Sinai
Location
Los Angeles, California
Salary
$24 - $33 / HOUR
Assist in the coordination and implementation of noncomplex research studies through data collection and participant scheduling. Support regulatory compliance by assisting with IRB submissions and maintaining GCP and HIPAA standards.
A high school diploma or GED is required, while a bachelor's degree is preferred. One year of clinical research experience is preferred.
Build rapport with community members and participants to support study engagement. Administer baseline and follow-up surveys and interviews (in Spanish and English). Maintain accurate and timely documentation, including data entry and management using REDCap. Analyze qualitative data using software such as Dedoose or ATLAS.ti. Analyze quantitative data using software such as SAS, STATA, or R. Extract and manage data from Electronic Medical Records (EMR). Conduct literature searches to support research and grant activities. Assist with regulatory submissions to the Institutional Review Board (IRB), including Adverse Events, Serious Adverse Events, and Safety Letters. Participate in study monitoring, auditing, and required trainings. Contribute to manuscript development and submission for peer-reviewed journals Contribute to the development of abstracts, posters, and presentations for conferences and community dissemination. Support NIH and other grant submissions, including preparing literature reviews, formatting biosketches, drafting supporting documents, and assisting with budgets and justifications. Works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies. Collects, evaluates and/or abstracts clinical research data. May assist in designing forms for data collection/abstraction. Enters and processes clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors. Completes Case Report Forms (CRFs). Assists with prescreening of potential research participants for various clinical trials. Schedules research participants for research visits and research procedures. Provides supervised patient contact or independent patient contact for long term follow-up patients only. Assists supervising staff with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines. Assists with clinical trial budgets and patient research billing. Responsible for sample preparation and shipping and maintenance of study supplies and kits. Ensures compliance with protocol and overall clinical research objectives. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board. Maintains research practices using Good Clinical Practice (GCP) guidelines. Maintains strict patient confidentiality according to HIPAA regulations and applicable law. May serve as one point of contact for external sponsors for select trials. May respond to sponsor inquiries and attend meetings regarding study activity under the direction of supervising staff.
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