Cedars-Sinai Clinical Research Coordinator III - Part-Time - Hepatology-Transplant Research in Los Angeles, California
Join Cedars-Sinai and become part of a team that is at the forefront of medical advancements!
Work alongside physician-scientists and researchers who are making life-saving medical and scientific breakthroughs. Our team of scientists develop some of the most advanced clinical trials in the world.
The research of Mazen Noureddin, MD, focuses on the underlying mechanisms of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH), new imaging modalities and exploring new treatments. He has conducted several original studies that have been featured in publications such as Gastroenterology, Hepatology and The American Journal of Gastroenterology, among many others. The Fatty Liver Program at Cedars-Sinai has many breakthrough clinical trials targeting new therapies in patients with non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitisn (NASH), including those with advanced fibrosis and cirrhosis.
As a Clinical Research Coordinator III (CRC III), you will work closely with the Division Program Manager, Clinical Research Coordinator Team and Scleroderma Center Investigators to harmonize clinical research and clinical care efforts by streamlining workflows as needed in the context of dynamic clinical setting. You will provide study coordination including screening of potential research participants for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Duties and Responsibilities:
Responsible for oversight of studies assigned within the group and provides support with managing the clinical research portfolio and daily operations of studies for the investigator or disease group.
Independent study coordination including screening of potential research participants for protocol eligibility, presenting non-medical trial concepts and details to the research participants, and participating in the informed consent process.
Scheduling of research participants for research visits and procedures.
In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in research participant condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
Maintains accurate source documents related to all research procedures.
Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
Schedules and participates in monitoring and auditing activities.
Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
Notifies direct supervisor about concerns regarding data quality and study conduct.
Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit initial applications, amendments, continuing reviews, Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
May involve other regulatory / Institutional Review Board duties, budgeting duties, and assisting with research participant billing and reconciliation.
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 research participant confidentiality according to HIPAA regulations and applicable law.
Participates in required training and education programs.
Works with Training and Education Coordinator to ensure all staff is properly trained and certified.
Participates in centralized activities such as auditing, Standard Operating Procedure development, etc.
Plans and coordinates strategies for increasing research participant enrollment, and/or improving clinical research efficiency.
Identifies quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality.
Identifies new research opportunities and presents to investigators.
Supervises other clinical research staff in day to day operations. Provides input in the performance review of other clinical research staff.
Organizes and leads routine research meetings.
Department-Specific Duties and Responsibilities:
Manages and grows human sample collection for repository as well as research databases of the Fatty Liver Disease Program.
Works on both industry sponsor initiated and investigator initiated clinical trials.
Provides training to junior level coordinators.
Prepares and manages clinical trial budgets.
Research medication handling and transporting between pharmacy and Comprehensive Transplant Center (CTC).
High School Diploma/GED, required.
Bachelors of Science, Sociology, or related field, preferred.
ACRP/SoCRA (or equivalent) certification, preferred.
Four (4) years clinical research related experience, required.
Three (3) years involvement in coordination of clinical research trials, required.
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.