Job Description

Clinical Research Associate I, Castellon-Lopez Lab at CEDARS-SINAI summary:

The Clinical Research Associate I collaborates with clinical staff to coordinate and implement research studies, ensuring adherence to protocols and regulatory guidelines. Responsibilities include data abstraction, case report form completion, regulatory submissions, patient scheduling, and maintaining compliance with FDA, IRB, and HIPAA regulations. The role also involves supporting clinical trial budgeting, patient billing, and research supply management while following Good Clinical Practice standards.

Job Description

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.

Req ID : 11708
Working Title : Clinical Research Associate I, Castellon-Lopez Lab
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, data abstraction, regulatory compliance, clinical trials, case report forms, IRB submissions, FDA regulations, patient scheduling, research data management, Good Clinical Practice

Job Tags

Local area, Shift work,

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