Clinical Research Coordinator I/CPT - MIRIAD Biobank - Inflammatory Bowel Disease Institute

Job Description

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.

Do you have a passion for helping humankind?

The Clinical Research Coordinator I works independently providing study coordination, 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 study information at regular research staff meetings. 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, response to study drug.
• Maintains accurate source documents related to all research procedures.
• Schedules and participates in monitoring and auditing activities.
• 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 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 assisting 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.
• Participates in required training and education programs.

Qualifications

Education:

• High School Diploma or GED is required.

Experience and Skills:

• 1 year of clinical research related experience and involvement in the coordination of clinical research trials is required.
• Computer skills, including Word and Excel, and the ability to use standard office equipment are required.

License/Certification/Registration:

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