Cedars-Sinai Clinical Research Associate I - Obstetrics/Prenatal Biorepository in Los Angeles, California
Cedars-Sinai is uniquely positioned at the forefront of translational research to improve women's health across a wide array of disciplines. The purpose of the Prenatal Repository is to gather tissue samples and data to investigate causes of pregnancy complications, such as delivering a premature or small baby and developing diabetes or hypertension during pregnancy. By collecting this information, researchers can explore the possibility of developing new methods of prenatal diagnosis that may be completed earlier or less invasively to identify women at risk. Additionally, samples and clinical information collected as part of this repository may be used to support future research that aims to further scientific knowledge about prenatal development.
To learn more about Women's Health Research, please visit: https://www.cedars-sinai.org/research/areas/womens-health.html
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:
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 IRB.
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.
- Bachelor's Degree in Science, Sociology or related degree (or equivalent education and experience), required.
Experience and Skillset:
- Ability to interpret and apply knowledge of State, Federal and Agency standards to comply with regulations.
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.