An exciting opportunity to join a dynamic research team at Cedars-Sinai. Under the leadership of Dr. Vanessa Torres, our team conducts community-engaged research and applies mixed-methods approaches to develop and test lifestyle interventions that address cancer risks and improve health outcomes.

The Clinical Research Associate I will work both independently and collaboratively with the research team to support the coordination and implementation of community-based studies. Responsibilities include participant recruitment and engagement, survey and interview administration, data collection and management, ensuring compliance with regulatory requirements, and contributing to the dissemination of findings. This is a hybrid position with a mix of on-site community work and remote responsibilities.

The Clinical Research Associate I works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study. Evaluates and abstracts research data and ensures compliance with protocol and research objectives. Responsible for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact as needed for study and assist with study budget and patient research billing. Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.

Primary Duties and Responsibilities

• 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 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.

Requirements:

• High School Diploma/GED required.

Preferred:

• Bachelor's Degree preferred.
• 1 year Clinical research related experience preferred.
• Spanish fluency required: This role requires expert-level fluency in Spanish, including the ability to read, write, and speak, as you will be working closely with Spanish-speaking populations.
• Transportation: Ability to drive with access to a personal vehicle for community-based research activities, including intervention delivery, data collection, participant follow-up, and dissemination of study findings.