Cedars-Sinai Clinical Research Associate I - Medically Associated Science & Technology Program in Los Angeles, California
The Medically Associated Science and Technology (MAST) program at Cedars-Sinai is dedicated to the development of novel drugs and devices to diagnose and treat patients. This innovative program is working to develop new diagnostics and therapeutics to treat patients with illnesses related to imbalances or alterations in the microbiome. Over the last 20 years, the MAST team has made many discoveries that benefit millions of patients, and we hope to help millions more with our growing fleet of novel diagnostics and therapeutics.
As a Clinical Research Associate I in MAST, you will work directly with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate and/or implement the study and may serve as the point of contact for the external sponsors.
In this role, you will evaluate and abstract research data and ensure compliance with protocol and research objectives and will be responsible for completing case report forms, entering clinical research data, and assisting with regulatory submissions to the IRB.
Additional Job Duties & Responsibilities:
Provides limited patient contact as needed for study and assists with study budget and patient research billing
May coordinate activities, training, and education for other Clinical Research Associates
Complies with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care
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) and works closely with supervising research staff or directly with the Institutional Review Board to submit 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
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
May serve as the point of contact for external sponsors for select trials
May participate in the development of Investigator Initiated trials for Investigational New Drug applications and/or Device applications
May have some percent of effort in centralized activities such as auditing, Standard Operating Procedure development, etc.
- Bachelor of Science or Bachelor of Arts degree required
- ACRP/SoCRA (or equivalent) certification preferred
- Two (2) years of directly related experience, or equivalent combination of education and experience
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.