Clinical Research Associate I
2 weeks ago
Position Overview
Key Responsibilities
The Clinical Research Associate I collaborates closely with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to facilitate and/or execute clinical studies.
This role involves evaluating and abstracting research data while ensuring adherence to study protocols and objectives. Responsibilities include completing case report forms, entering clinical research data, and assisting with regulatory submissions to the Institutional Review Board (IRB). Limited patient interaction may be required for study purposes, along with support for study budgeting and patient research billing.Ensures compliance with all applicable federal, local, FDA, IRB, and HIPAA regulations regarding the study and patient care.
Primary Duties• Collaborates with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to facilitate study execution.
• Evaluates and abstracts clinical research data from primary source documents.
• Ensures adherence to study protocols and overall clinical research objectives.
• Completes Case Report Forms (CRFs).
• Inputs clinical research data into Electronic Data Capture (EDC) systems provided by sponsors.
• Provides supervised patient contact or engages with long-term follow-up patients as necessary.
• Assists with regulatory submissions to the Institutional Review Board (IRB), including reporting Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
• Aids in managing clinical trial budgets.• Supports patient research billing.
• Schedules patient appointments for research visits and procedures.
• Responsible for sample preparation, shipping, and maintaining study supplies and kits.
• Ensures compliance with all federal and local regulations, including those set forth by the Food and Drug Administration (FDA) and local Institutional Review Board.
• Upholds research practices in accordance with Good Clinical Practice (GCP) guidelines.• Maintains strict patient confidentiality in line with HIPAA regulations and applicable laws.
• Participates in mandatory training and educational programs.
Qualifications
Educational Background:
- High school diploma/GED required
- Bachelor's degree in Science, Sociology, or a related field preferred
Licenses:
- Phlebotomy Certification required
Experience:
Preferred 1 year of clinical research experience
Physical Requirements:
- Ability to perform moderate lifting.
- Capable of sitting, standing, and walking for extended periods.
- Proficient in reading documents and online materials.
- Able to operate standard office equipment.
- Possesses the physical ability and visual acuity to effectively perform essential job functions.
About Cedars-Sinai
Cedars-Sinai is a prominent institution in delivering high-quality healthcare, encompassing primary care, specialized medicine, and research.
Since its inception, Cedars-Sinai has adapted to meet the diverse needs of the community, setting benchmarks in quality and innovative patient care, research, education, and community service.
Today, Cedars-Sinai is recognized for its national leadership in advancing healthcare for the benefit of patients. The institution influences the future of healthcare by developing new treatment methodologies and educating the next generation of health professionals. Additionally, Cedars-Sinai is committed to community service through programs aimed at improving the health of its most vulnerable populations.About the Team
Cedars-Sinai stands as one of the largest nonprofit academic medical centers in the United States, featuring 886 licensed beds, 2,100 physicians, 2,800 nurses, and thousands of other healthcare professionals and staff.
This position is ideal for individuals seeking to work in a dynamic environment that provides the highest level of care to those in need.
Req ID:
HRC
Working Title:
Clinical Research Associate I - Cheng Laboratory
Department:
Heart Institute
Business Entity:
Cedars-Sinai Medical Center
Job Category:
Academic / Research
Job Specialty:
Research Studies/ Clinical Trials
Overtime Status:
NONEXEMPT
Primary Shift:
Day
Shift Duration: 8 hours
Base Pay:
$29.87
Cedars-Sinai is an equal opportunity employer.
Cedars-Sinai does not unlawfully discriminate based on race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical conditions, marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status, or any other basis protected by federal or state law.
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