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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 under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies. Supports objectives of research studies through noncomplex tasks such as data collection, prescreening of potential and scheduling of current research participants, assisting in IRB submission activities, budget and billing, and ensuring overall compliance with all federal and local guidelines.

Primary Duties and Responsibilities:

• Collects, evaluates and/or abstracts clinical research data. May assist in designing forms for data collection/abstraction. Enters and processes clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
• Completes Case Report Forms (CRFs).
• Assists with prescreening of potential research participants for various clinical trials. Schedules research participants for research visits and research procedures. Provides supervised patient contact or independent patient contact for long term follow-up patients only.
• Assists supervising staff 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 and patient research billing.
• Responsible for sample preparation and shipping, and maintenance of study supplies and kits.
• Ensures compliance with protocol and overall clinical research objectives. 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.
• May serve as one point of contact for external sponsors for select trials. May respond to sponsor inquiries and attend meetings regarding study activity under the direction of supervising staff.

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 the 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 off-site location.
• Facilitate lab maintenance, coordinating with other lab personnel.
• This position may require on-site training by other experienced clinical research associates.

Licenses and Certifications:

• Phlebotomy Certification CA is required upon hire.
• Valid CA Driver's License is required.

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.