Cedars-Sinai Clinical Research Associate I - Per Diem - Hepatology-Transplant Research in Los Angeles, California
When the work you do every single day has a crucial impact on the lives of others, every effort, every detail, and every second matters. This shared culture of happiness, passion, and dedication pulses through Cedars-Sinai.
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 Associate I, you will work directly with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate and/or implement the study. This role evaluates and abstracts research data, and ensures compliance with protocol and research objectives. Position is responsible for completing case report forms (CRFs), entering clinical research data, and assisting with regulatory submissions to the Institutional Review Board (IRB). The CRA I may have limited contact with research participants as needed for study and assists with study budget and research participant billing. This role follows all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.
Primary Job Duties and Responsibilities:
Works with a Clinical Research Coordinator, Research Program Administrator, Research Nurse or Principal Investigator 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 contact with research participants or contact for long term follow-up research participants 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.
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.
Department-Specific Duties and Responsibilities:
Responsible for abstracting required data; collecting complex data elements from individual patient records; ensuring the integrity of the electronic data transmitted to established databases (internal and external).
Keeps meticulous records and presents results to the team.
Maintains computer database with relevant clinical information.
Assists with monitoring and analyzing data.
Demonstrates an understanding of the outcomes and the overall clinical data review goals in meeting the objectives of the protocol.
Works closely with other protocol team members to meet the appropriate timelines for data cleaning requirements at the site level.
Participates in the development of data reports for internal and external reporting.
Required to become familiar with current GCP/IRB best practices and guidelines.
High School Diploma/GED, required.
Bachelors of Science, Sociology or related degree, preferred.
Experience and Skillset:
Clinical Research experience is highly preferred.
Understanding of general research objectives.
Ability to understand regulatory requirements impacting matters within assigned scope of responsibility, data abstracting and entry methodologies.
Understanding of general research objectives.
Working knowledge of clinical database management.
Strong computer skills with proficiency in Word, Excel, PowerPoint, etc.
Proficient with statistical methods for clinical databases and REDCap a plus.
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.