Cedars-Sinai · 1 month ago
Clinical Research Associate I (Hybrid, Per Diem) – Thai & Asian Community Health Initiatives
6500 Wilshire Blvd, Los Angeles, CA, 90048, US
Full-time
Hybrid
New Grad, Entry Level
$19.50/hr - $32.86/hrCedars-Sinai is seeking a Clinical Research Associate I to support community-based research initiatives within the Thai community. The role involves coordinating research activities, ensuring compliance with protocols, and engaging with participants to improve cancer prevention and health outcomes.
CommunitiesHealth CareMedicalNon Profit
Responsibilities
Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study
Evaluates and abstracts clinical research data from source documents
Ensures compliance with protocol and overall clinical research objectives
Completes Case Report Forms (CRFs)
Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors
Provides supervised patient contact or patient contact for long term follow-up patients only
Assists 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
Assists with patient research billing
Schedules patients for research visits and research procedures
Responsible for sample preparation and shipping and maintenance of study supplies and kits
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
Participates in required training and education programs
Works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to support the coordination and implementation of non-complex research studies
Collects, evaluates, and abstracts clinical research data; may assist in designing data collection/abstraction tools. Enters and processes clinical research data into sponsor-provided Electronic Data Capture (EDC) systems
Completes Case Report Forms (CRFs) in accordance with study protocols and sponsor requirements
Assists with prescreening potential research participants for various clinical trials. Schedules participants for research visits and procedures. Provides supervised patient contact or independent contact for long-term follow-up participants
Assists supervising staff with regulatory submissions to the Institutional Review Board (IRB), including the submission of Adverse Events, Serious Adverse Events, and Safety Letters per federal and local guidelines
Assists with clinical trial budgets, study-related billing, and patient research billing activities
Prepares and ships biological samples; maintains study supplies, kits, and inventory
Ensures compliance with study protocols, Good Clinical Practice (GCP), FDA regulations, IRB requirements, HIPAA standards, and all institutional and federal guidelines. Maintains strict patient confidentiality
Serves as a point of contact for external sponsors for select trials; responds to sponsor inquiries and may attend meetings regarding study activity under supervision
Assists with prescreening of potential study participants
Maintains organized paper and electronic research files
Assists with preparing manuscripts, correspondence, and other research documents
Conducts literature reviews to support study activities
Transports research medications according to protocol requirements
Performs study-related assessments and participant questionnaires
Qualification
Required
Ability to commute to the Los Angeles work location several times per week
Ability to work between 0 and 40 hours per week, depending on departmental needs
Experience in coordinating and implementing clinical research studies
Knowledge of clinical research protocols and objectives
Ability to evaluate and abstract clinical research data from source documents
Experience completing Case Report Forms (CRFs)
Proficiency in entering clinical research data into Electronic Data Systems (EDCs)
Ability to assist with regulatory submissions to the Institutional Review Board (IRB)
Knowledge of federal, local, FDA, IRB, and HIPAA guidelines and regulations
Experience with patient contact for study purposes
Ability to assist with clinical trial budgets and patient research billing
Experience scheduling patients for research visits and procedures
Ability to prepare and ship biological samples and maintain study supplies
Knowledge of Good Clinical Practice (GCP) guidelines
Ability to maintain strict patient confidentiality according to HIPAA regulations
Participation in required training and education programs
Preferred
Proficiency in the Thai language is strongly preferred
Company
Cedars-Sinai
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
10001+ employees
Funding
Current Stage
Late StageTotal Funding
$63.31MKey Investors
American Academy of Orthopaedic SurgeonsCalifornia HealthCare FoundationNational Heart, Lung and Blood Institute
2023-12-01Grant· $0.01M
2023-05-25Grant· $28M
2022-06-16Grant· $7M
Leadership Team
Thomas Priselac
President/CEO
David Wrigley
Executive Vice President Finance, CFO and Treasurer
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