Clinical Research Associate II - Yang Lab - Karsh Division of Gastroenterology and Hepatology

Job Description

When the work you do every single day has a crucial impact on the lives of others, every effort, every detail, and every second matters. This shared culture of happiness, passion, and dedication pulses through Cedars-Sinai.

We invite you to consider this phenomenal opportunity!

Dr. Ju Dong Yang, in Department of Medicine, Karsh Division of Gastroenterology and Hepatology is looking for a new Clinical Research Associate II to join the team!

The research program of Dr. Ju Dong Yang has been focused on clinical and translational research of liver cancer. Dr. Yang conducted several population-based cohort studies to describe recent trends in liver cancer epidemiology in the United States.

The Clinical Research Associate II works independently but in close collaboration with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, other supervising staff to coordinate and/or implement increasingly complex research studies. Supports objectives of research studies through noncomplex tasks such as data collection, prescreening and scheduling of current research participants, assisting in IRB submission activities, and budget and billing, and ensuring overall compliance with all federal and local guidelines.

Provides increasingly complex and independent support for studies by serving as the independent contact with sponsors, IRB, and research participants, providing training, education to junior level staff, and coordination of ad hoc activities related to studies.

This position is onsite
.

Primary

Job Duties and 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.

Department-Specific Responsibilities:

• 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…