Cedars-Sinai · 8 hours ago
Clinical Research Associate II - Yang Lab - Karsh Division of Gastroenterology and Hepatology (Onsite)
Cedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. The Clinical Research Associate II works independently and collaborates with various staff to coordinate and implement complex research studies, ensuring compliance with federal and local guidelines.
CommunitiesHealth CareMedicalNon Profit
Responsibilities
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)
Independently prescreens research participants for various clinical trials
Schedules research participants for research visits and research procedures
May provide increasingly independent contact with research participants and/or conduct research participant visits independently
Assists supervising staff with regulatory submissions to the Institutional Review Board (IRB). May work directly with the Institutional Review Board to submit Adverse Events, Serious Adverse Events, Safety Letters, etc in accordance with local and federal guidelines
Assists with clinical trial budgets and patient billing
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 and provides training and education to other Clinical Research Associates
May assist in coordinating activities of other associates to ensure compliance with protocol and clinical research objectives
Participates in centralized activities such as auditing, Standard Operating Procedure development, etc
May participate in the development of Investigator Initiated trials for Investigational New Drug applications and/or Device applications
May provide coordination of minimal number of noncomplex research studies or projects independently. May provide coverage for study coordination activities of supervising staff when needed to ensure minimal disruption to study objectives
Serves as primary Biobank coordinator, responsible for day-to-day operations of Dr. Yang’s bio-specimen repositories. Will focus on receiving, processing e.g., centrifugation, aliquoting, labeling storing, tracking, and shipping biological specimens according to study protocols and institutional standards
Maintains Biobank inventory and documentation, supports quality assurance, and provides limited back-up support for low-risk research projects (e.g., liquid biopsy) that involve minimal direct patient interaction
Coordinates with research coordinators, clinical staff, and laboratory personnel to ensure samples are collected, processed, and stored within protocol-specified time frames. Communicates proactively with the research team regarding sample issues, supply needs, and workflow challenges
Maintains organized, accurate specimen inventories in laboratory freezers and refrigerators; performs routine inventory reconciliation and freezer audits. Prepares and package bio-specimens for shipment to external laboratories, CROs, or central Biobank in compliance with IATA and institutional requirements
Maintains Biobank documentation including SOPs, processing logs, temperature logs, deviation records, and shipping records. Assists with development and periodic review of Biobank SOPs and workflows to improve efficiency and quality. Supports simple data entry for Biobank-related databases and trackers (e.g., REDCap, Excel) and generates basic reports on specimen collections and usage
Performs lab and equipment maintenance duties, maintains lab supply inventories, and places orders for equipment and supplies
Participates in required safety and compliance training (e.g., biosafety, IATA, GCP/human subjects' protection as applicable)
Qualification
Required
High School Diploma/GED is required
1 year of clinical research related experience is required
Preferred
Bachelor's degree in Science, Sociology, or related degree is preferred
ACRP/SoCRA certification is preferred
Experience with basic laboratory techniques (e.g., pipetting, centrifugation, aliquoting) and accurate labeling and documentation is highly 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.
H1B Sponsorship
Cedars-Sinai has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (105)
2024 (91)
2023 (81)
2022 (92)
2021 (92)
2020 (65)
Funding
Current Stage
Late StageTotal Funding
$63.31MKey Investors
American Academy of Orthopaedic SurgeonsCalifornia HealthCare Foundation"National Heart, Lung and Blood Institute"
2023-12-01Grant· $0.01M
2023-05-25Grant· $28M
2022-06-16Grant· $7M
Leadership Team
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