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

Cedars-Sinai Medical Center•Los Angeles, CA

6d•Onsite

About The Position

The Clinical Research Coordinator II independently coordinates clinical research studies in pediatric neurology. The role screens potential patients for protocol eligibility, presents non-medical trial information, participates in informed consent, schedules research visits and procedures, and works with physicians and other medical personnel to document study-related information. The coordinator is responsible for accurate and timely source documentation, data collection, entry, reporting, and responses to sponsor queries, as well as compiling study information and presenting it at research staff meetings. The position ensures compliance with federal and local requirements, including FDA and IRB requirements, Good Clinical Practice guidelines, and HIPAA confidentiality rules. It may also involve regulatory and budget duties, patient billing and reconciliation, training personnel, quality improvement, enrollment strategies, and identifying new research opportunities.

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, including screening potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in informed consent.
Schedule patients for research visits and procedures.
Document changes in patient condition, adverse events, concomitant medication use, protocol compliance, and response to study drug on Case Report Forms in collaboration with physicians and other medical personnel.
Maintain accurate source documents for all research procedures.
Collect, document, enter, and report data accurately and promptly, including responding to sponsor queries in a timely manner.
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 about concerns regarding data quality and study conduct.
Work with a regulatory coordinator or directly with the IRB to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
May perform other regulatory or IRB duties, budgeting duties, and assist with patient research billing and reconciliation.
Ensure compliance with federal and local agencies, including the FDA and IRB.
Maintain research practices in accordance with Good Clinical Practice guidelines and protect patient confidentiality in accordance with HIPAA and applicable law.
May coordinate training and education of other personnel.
May participate in centralized activities such as auditing and Standard Operating Procedure development.
May plan and coordinate strategies to increase patient enrollment or improve clinical research efficiency.
May identify quality and performance improvement opportunities and collaborate with staff to develop action plans.
May identify new research opportunities and present them to investigators.
Participate in required training and education programs.