Clinical Research Coordinator I/CPT - Women's Health Program - Inflammatory Bowel Disease Center

Cedars-Sinai•Los Angeles, CA

8d•$25 - $41•Onsite

About The Position

Cedars-Sinai’s Women's Health in Inflammatory Bowel Disease (IBD) program addresses sex-specific challenges like fertility, pregnancy, and hormonal shifts. 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. This role is responsible for accurate and timely source documents, data collection, documentation, entry, and reporting, including timely response to sponsor queries. The coordinator is also responsible for compiling and reporting on each study, including information related to protocol activity, accrual data, workload, and other research information. They will present study information at regular research staff meetings and ensure compliance with all federal and local agencies, including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

Requirements

Clinical Research Coordinator I works independently providing study coordination
Screening of potential patients for protocol eligibility
Presenting non-medical trial concepts and details
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)
Maintains research practices using Good Clinical Practice (GCP) guidelines
Maintains strict patient confidentiality according to HIPAA regulations and applicable law
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/HIPPA 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
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 offsite location
Facilitate lab maintenance, coordinating with other lab personnel

Nice To Haves

May assist in designing forms for data collection/abstraction
May assist with prescreening of potential research participants for various clinical trials
May assist supervising staff with regulatory submissions to the Institutional Review Board (IRB)
May assist with clinical trial budgets and patient research billing
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

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.
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/HIPPA 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 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 offsite location.
Facilitate lab maintenance, coordinating with other lab personnel.