Clinical Research Coordinator II - Guerin Children's - Pediatric Neurology - Full-Time, On-Site, Days

Cedars-Sinai•Los Angeles, CA

7d•$60,029 - $102,045•Onsite

About The Position

The Clinical Research Coordinator II independently coordinates clinical studies, including screening potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in informed consent. The coordinator schedules research visits and procedures and works with physicians and other medical personnel to document patient-condition changes, adverse events, concomitant medication use, protocol compliance, and response to study drugs on Case Report Forms (CRFs). The role maintains accurate source documents and is responsible for timely data collection, documentation, entry, and reporting, including responding to sponsor queries. It compiles and reports study information such as protocol activity, accrual, and workload, and presents this information at regular research staff meetings. The coordinator also schedules and participates in monitoring and auditing activities and raises concerns about data quality or study conduct with the direct supervisor. The coordinator works with a regulatory coordinator or the Institutional Review Board (IRB) to submit adverse events, serious adverse events, protocol deviations, and safety letters in accordance with applicable guidelines. The role may also perform regulatory and IRB duties, budgeting, patient research billing and reconciliation, personnel training, auditing, and Standard Operating Procedure development. Additional possible activities include developing strategies to increase enrollment or improve research efficiency, identifying quality-improvement opportunities and new research opportunities, and presenting those opportunities to investigators. The position requires compliance with federal and local requirements, Good Clinical Practice (GCP), and HIPAA confidentiality requirements, as well as participation in required training and education programs.

Requirements

High school diploma or GED required.
Two years of clinical research-related experience required.

Nice To Haves

Bachelor's degree in science, sociology, or a related field preferred.
SOCRA or ACRP certification preferred.

Responsibilities

Independently coordinate studies, screen potential patients for protocol eligibility, present non-medical trial concepts and details, and participate in informed consent.
Schedule patients for research visits and procedures.
Work with physicians and other medical personnel to document patient-condition changes, adverse events, concomitant medication use, protocol compliance, and response to study drugs on Case Report Forms (CRFs).
Maintain accurate source documents related to research procedures.
Collect, document, enter, and report data accurately and on time, including responding to sponsor queries.
Schedule and participate in monitoring and auditing activities.
Compile and report study information, including protocol activity, accrual data, workload, and other research information, and present it at regular research staff meetings.
Notify the direct supervisor of concerns about data quality or study conduct.
Coordinate with a regulatory coordinator or the IRB to submit adverse events, serious adverse events, protocol deviations, and safety letters in accordance with applicable guidelines.
Ensure compliance with federal and local agencies and requirements, including FDA and IRB requirements.
Maintain research practices according to Good Clinical Practice (GCP) guidelines and protect patient confidentiality under HIPAA and applicable law.
May perform regulatory or IRB duties, budgeting, and patient research billing and reconciliation.
May coordinate training and education for other personnel and participate in centralized activities such as auditing and Standard Operating Procedure development.
May plan strategies to increase patient enrollment or improve clinical research efficiency.
May identify quality and performance improvement opportunities and collaborate on action plans.
May identify new research opportunities and present them to investigators.
Participate in required training and education programs.