Job Description

Bilingual Clinical Research Associate I – Ramin Lab (Spanish) at CEDARS-SINAI summary:

The Bilingual Clinical Research Associate I at Ramin Lab works closely with Spanish-speaking populations to coordinate and implement clinical research studies. Responsibilities include data abstraction, regulatory submissions, patient scheduling, and ensuring compliance with federal and local guidelines such as FDA, IRB, and HIPAA. The role requires expert-level Spanish fluency, occasional outreach travel, and entails assisting with study budget, patient billing, and maintaining research supplies.

Job Description

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 a Spanish-speaking population.

Flexible schedule : We are open to both full-time and part-time availability, depending on the needs of the selected candidate.

Outreach travel : The position includes occasional day trips to Bakersfield for outreach activities with the team.

Transportation : While having your own vehicle is a plus, it is not required—transportation will be provided for outreach travel.

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

• 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.

Qualifications

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 a Spanish-speaking population.

Flexible schedule : We are open to both full-time and part-time availability, depending on the needs of the selected candidate.

Outreach travel : The position includes occasional day trips to Bakersfield for outreach activities with the team.

Transportation : While having your own vehicle is a plus, it is not required—transportation will be provided for outreach travel.

Req ID : 11244
Working Title : Bilingual Clinical Research Associate I – Ramin Lab (Spanish)
Department : Cancer - Research Center Health Equity
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : NONEXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $19.50 - $32.86

Keywords:

clinical research, Spanish fluency, data abstraction, regulatory compliance, patient scheduling, FDA, HIPAA, clinical trials, research coordination, outreach travel

Job Tags

Full time, Part time, Local area, Flexible hours, Shift work,

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