Clinical Research Associate I: Breakthrough Trials

Cedars-Sinai; Los Angeles (CA); On-site; USD 65,000 - 90,000; Full time

Job summary

Cedars-Sinai Medical Center in Los Angeles seeks a Clinical Research Associate I to support study coordination, data collection, and regulatory compliance. You will work with a Clinical Research Coordinator or Research Nurse to implement trials, collect CRFs, and ensure adherence to protocol, HIPAA, and GCP guidelines.

Responsibilities include data entry into sponsor systems, assisting with budgeting and patient scheduling, and preparing samples and study materials.

Qualifications

• High School Diploma is required; Bachelor's degree is preferred in Science, Sociology, or a related field.
• One year of clinical research related experience is preferred.

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 the sponsors provide.
• 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 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.

Skills

Clinical research experience

Education

High School Diploma; Bachelor's preferred in Science/Sociology

Job description

Cedars-Sinai Medical Center in Los Angeles seeks a Clinical Research Associate I to support study coordination, data collection, and regulatory compliance. You will work with a Clinical Research Coordinator or Research Nurse to implement trials, collect CRFs, and ensure adherence to protocol, HIPAA, and GCP guidelines.

Responsibilities include data entry into sponsor systems, assisting with budgeting and patient scheduling, and preparing samples and study materials.