- 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
- High School Diploma/GED
- 1 year Clinical Research Related Experience
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CEDARS-SINAI Los Angeles, United StatesJob 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 rese ...
Clinical Research Associate I, Castellon-Lopez Lab - Los Angeles, United States - Cedars-Sinai
Description
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.
Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.
Primary Duties and ResponsibilitiesQualifications
Requirements:
Req ID : 1636
Working Title :
Clinical Research Associate I, Castellon-Lopez Lab (Onsite)
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 :
$ $29.87
Cedars-Sinai is an EEO employer.
Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), 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.