"Clinical Research Coordinator I - Guerin Children's - Developmental-Behavioral Pediatrics - Full-Time, On-Site, Days"

Job Description

Grow your research career at Cedars-Sinai Guerin Children's! To learn more, please visit: Cedars-Sinai Guerin Children's.

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 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.

Qualifications

Educational, Certification, and Experience Requirements:

• High School Diploma/GED required. Bachelor's Degree in Science, Sociology or related degree preferred.
• SOCRA or ACRP Certification preferred upon hire
• One (1) year of clinical research related experience required.
• Experience with gene therapy clinical trials and pediatric populations preferred.
• Experience with clinical trial budgeting and regulatory for FDA-regulated therapeutics preferred.

Req ID: 15281
Working Title: Clinical Research Coordinator I - Guerin Children's - Developmental-Behavioral Pediatrics - Full-Time, On-Site, Days
Department: Research - Pediatrics
Business Entity: Cedars-Sinai Medical Center
Job Category: Academic / Research
Job Specialty: Research Studies/ Clin Trial
Overtime Status: NONEXEMPT
Primary Shift: Day
Shift Duration: 8 hour
Base Pay: $24.00 - $39.76