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.

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 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:

• Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.
• 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.
• Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
• Schedules and participates in monitoring and auditing activities.
• Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
• 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.
• 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:

• Supports daily clinical research and biobank operations for assigned IBD studies and research initiatives under the direction of investigators and senior research staff.
• Assists with participant recruitment, screening, scheduling, enrollment, and informed consent processes in accordance with IRB-approved protocols and institutional policies.
• Performs CPT-related clinical tasks within scope of certification and training, including blood collection, specimen handling, processing, labeling, storage, and shipment to support study and biobanking activities.
• Coordinates participant visits and study procedures across outpatient clinics, infusion centers, procedural areas, and laboratory environments to support continuity of research operations.
• Maintains accurate and timely research documentation, source documents, case report forms, study logs, and regulatory binders in accordance with sponsor, institutional, and regulatory requirements.
• Enters and maintains clinical research and biobank data within REDCap, OnCore, Epic, LabVantage, and other approved research systems while ensuring data integrity and quality.
• Assists with preparation and maintenance of IRB submissions, amendments, continuing reviews, deviations, and other regulatory documentation.
• Supports biospecimen collection workflows including blood, stool, tissue, and biopsy collection activities while ensuring proper chain of custody and protocol compliance.
• Maintains study supply inventory, specimen collection kits, and laboratory materials required for daily clinical research operations.
• Collaborates with physicians, nurses, laboratory personnel, study sponsors, and multidisciplinary research teams to support protocol implementation and participant retention.
• Provides support for study monitoring visits, audits, sponsor requests, and internal quality reviews by organizing and preparing required documentation.
• Assists with participant education and communication regarding study requirements, visit schedules, specimen collection instructions, and follow-up activities.
• Adheres to all institutional safety, infection prevention, HIPAA, human subjects protection, and Good Clinical Practice (GCP) requirements.
• Supports process improvement efforts related to clinical research workflows, participant experience, data collection, and biobank operations.
• May assist senior coordinators and leadership with training new staff, coordinating study-related tasks, and supporting operational coverage needs across the department.

Qualifications

Experience and Skills:

• One (1) year of clinical research related experience is required.
• 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 and Certification:

• 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.

 

Physical Demands:
 

• Able to perform moderate lifting. 
• Able to sit, stand and walk for prolonged periods of time. 
• Able to read papers and online documents. 
• Able to operate standard office equipment. 
• Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.