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This shared culture of happiness, passion, and dedication pulses through Cedars-Sinai, and it’s just one of the many reasons why we rank as one of the top hospitals in the nation by U.S. News & World Report. From working with a team of committed healthcare professionals to using state-of-the-art facilities, you’ll have everything necessary to do something incredible—for yourself and for others.

Do you have a passion for helping humankind?

The Clinical Research Coordinator III 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 oversight of all studies with the group and the assignment of studies to clinical research personnel within the group, and supervision of research staff. Plans and coordinates strategies for increasing patient enrollment, improving efficiency, training of personnel, and 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:

• 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.
• Scheduling of 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 involve 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.
• Works with Training and Education Coordinator to ensure all staff is properly trained and certified.
• Participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
• Plans and coordinates strategies for increasing patient enrollment, and/or improving clinical research efficiency.
• Identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
• Identifies new research opportunities and presents to investigators.
• Supervises other research staff.

Department Specific Responsibilities:

• Responsible for research or clinical trial studies including patient chart review, clinical phenotyping, data analysis, direct patient contact, answering patients questions, shipping of supplies to patients, biobanking of samples, registration of patients, scheduling, accessioning, and auditing of data.
• Must possess strong scientific background in gross anatomy, histology, pathology, and pharmacology.
• Ability to interpret and analyze surgical pathology reported on PowerPath and must be fluent in Epic.
• Must be familiar with drug classifications and recording clinical response/adverse/side effects.
• May validate large subsets of clinical patient data.
• Must have strong hands-on clinical experience and skills and feel comfortable routinely interacting with patients in a clinical setting.
• Responsibilities include using new data programs such as Tablaeu, Docker, Powerpath, RedCap, Labvantage, and Aquity.
• Provides training for patient registration in clinic, enhancement of communication skills, and on use of other programs such as RedCap and Aquity.
• May attend and participate in annual scientific meetings and present plenary session presentations and/or create and present oral e-/posters to scholarly conferences and other work-related functions. Assist in preparation of data and abstract writing for publiction.
• May supervise Clinical Research Associates on data entry, data query, and resolution as well as chart review.
• May identify new research opportunities and present to investigators. Works with investigators to make significant academic and creative contributions as well as aiding in design and implementation of studies.
• Assist with designing database/data architecture transitions.
• Part of the Information Technology (IT) team - IBIRI Phenomics Data Management, LVS Team and Event Driven Phenotype Team. Works directly with Bio-informaticians and Senior Project Research Advisor and Project Scientists to ensure ETL jobs run daily and department IT operations and overall administration of day-to-day operations.
• Works directly with Project Scientist MD as one of two phenotypers in the department to accurately diagnose IBIRI patients as CD or UC daily by analyzing x-ray/CT scan images, laboratory values, pathology/biopsy reports, operative notes, and GI consultant visit notes in the chart, and update the appointment report daily for the department using Tablaeu, RedCap MICS and EPIC.
• Works directly with scientists and is responsible for constructing clinical analyzation of surgical pathology reports and chart review of disease involved and uninvolved specimens and interprets clinician's notes which requires medical degree background.

Education:

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

Licenses and Certifications:

• Valid CA driver's license is required.

Experience and Skills:

• Four (4) years 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.