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The Material and Information Resources for Inflammatory and Digestive Diseases (MIRIAD) Biobank is the central hub of a full-circle approach to the study of inflammatory bowel disease (IBD). MIRIAD acquires, processes, stores, evaluates and distributes human specimens, which are maintained in association with the triad of accurate longitudinal clinical metadata, comprehensive genotype information and serotypes. These resources are made available to research partners within IBIRI and Cedars-Sinai, and with collaborators around the world.

Specimens have been collected from thousands of subjects over 3 decades. Clinical and research data are stored in an extensive database/LIMS system customized specifically for this purpose. The database is also used to monitor subject participation, assure regulatory compliance and to manage inventory. Collectively, MIRIAD's capabilities permit the rapid assembly and dispersal of homogenous cohorts for investigation.To learn more, please visit: MIRIAD IBD Biobank & Database | Cedars-Sinai.

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:

• Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse 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 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 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 Responsibilities:

• Understand and implement the current IRB/HIPAA regulatory rules and research protocol details.
• Communicate accurately and effectively with research subjects, clinicians, and researchers from diverse backgrounds.
• Work in various hospital environments during surgeries and endoscopies to obtain specimens for research.
• Assists with prescreening of potential research participants for various research projects and studies.
• Attends research meetings and monthly conference calls.
• Enter and maintain accurate patient/study data in databases.
• Database (LabVantage, Redcap) and advanced Excel spreadsheet entry of study resources in the process of sample banking.
• Perform laboratory procedures to prepare samples for further experiments, storage, or shipping, including DNA extraction and quantification from saliva and cell pellets.
• Collect specimens from an offsite location.
• Facilitate lab maintenance, coordinating with other lab personnel.
• This position may require on-site training by other experienced clinical research associates.

Education:

• High School Diploma/GED, is required. Bachelor's degree preferred.

Experience and Skills:

• One (1) year of clinical research related experience is preferred.
• Ability to interpret and apply knowledge of State, Federal and Agency standards to comply with regulations.
• Ability to convey and/or receive written/verbal information to/from various audiences in different formats.
• Computer skills, including Word and Excel, and ability to use standard office equipment is required.