Join us for an exciting opportunity with one of the most outstanding and dynamic places known nationally for excellence in IBD research!

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 manage inventory. Collectively, MIRIAD's capabilities permit the rapid assembly and dispersal of homogeneous cohorts for investigation.

Do you have a passion for helping humankind?

The Clinical Research Coordinator II works independently, providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting, including timely response to sponsor queries. Responsible for compiling and reporting on each study, including information related to protocol activity, accrual data, workload, and other research information. Presents information at regular research staff meetings. May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities. Ensures compliance with all federal and local agencies, including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

Primary Job Duties and Responsibilities:

• Schedules patients 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 patient condition, adverse events, concomitant medication use, protocol compliance, and response to study drug.
• Maintains accurate source documents related to all research procedures.
• Schedules and participates in monitoring and auditing activities.
• Notifies the 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 Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
• May perform other regulatory / Institutional Review Board duties, budgeting duties, and assist with patient research billing and reconciliation.
• Maintains research practices using Good Clinical Practice (GCP) guidelines.
• Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
• May coordinate training and education of other personnel.
• May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
• May plan and coordinate strategies for increasing patient enrollment, and/or improving clinical research efficiency.
• May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
• May identify new research opportunities and present to investigators
• Participates in required training and education programs.

Department Specific Responsibilities:

• Performs phlebotomy services according to CSMC policies and procedures.
• Verifies specimen identification, assesses appropriateness of test orders and quality of specimen by recognizing factors that affect procedures and results; takes appropriate action when corrections are indicated.
• Identifies patients and patient samples by strict adherence to established procedures; labels samples accurately and completely. Reports test results to appropriate individuals and exercises professional discretion with patient information.
• 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.
• 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.

Education:

• High School Diploma, is required. A bachelor's Degree is preferred.

Experience and Skills:

• Two (2) years of clinical research related experience and involvement in the coordination of clinical research trials.
• Ability to use discretion and maintain privacy, confidentiality, or anonymity.
• 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 the ability to use standard office equipment are required.

License/Certification/Registration Requirements:

• Valid CA Driver's License is required.
• California Certified Phlebotomy Technician I or Certified Phlebotomy Technician II certification, required.
• ACRP/SoCRA (or equivalent) certification, preferred.