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.
Providing healthcare for more than 100 years, Cedars-Sinai has evolved into one of the most dynamic and highly renowned medical centers in the world. Along with caring for patients, Cedars-Sinai is a hub for biomedical research and a training center for future physicians and other healthcare professionals. This attracts exceptional talent to Cedars-Sinai, including world-renowned physician-scientists who seek a place where they can both conduct research and see patients--the ideal formula for discovery and its translation into cures. Our patients benefit from access to doctors at the top of their fields, and our researchers have an ideal community in which to study the impact of healthcare challenges, and reflect that knowledge in their research. The greater Los Angeles area in which Cedars-Sinai resides possesses unparalleled cultural and ethnic diversity which offers outstanding opportunities for translational and clinical research and a dynamic environment for medical education.Although community based, Cedars-Sinai is a major t...eaching hospital affiliated with the David Geffen School of Medicine at the University of California, Los Angeles (UCLA). Cedars-Sinai has highly competitive graduate medical education programs in more than 50 specialty and subspecialty areas, a graduate program in biomedical sciences and translational medicine, a clinical scholars program directed towards junior physicians with aspirations to become clinical scientists, and post graduate training opportunities.There are more than 250 full-time faculty members at Cedars-Sinai. The voluntary medical staff, comprised of more than 2,200 specialty board-certified or board-qualified physicians, represent all of the specialties and subspecialties and collaborate with full-time medical staff in the teaching responsibilities of the graduate medical education programs.