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in Fresno, CA
Clinical Research Coordinator III - Guerin Children's - Pediatric Neurology/Neurosurgery (Full-Time, On-Site)
Estimated Pay | $63 per hour |
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Hours | Full-time, Part-time |
Location | Fresno, CA, United States Fresno, California |
Compare Pay
Estimated Pay$37.66
$62.50
$81.98
About this job
Guerin Children’s is launching an innovative program in pediatric epilepsy and neurogenic rare diseases, including genomic sequencing and clinical trials with advanced therapy medicinal products (ATMPs).
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 Pediatric Neurology/Neurosurgery clinical trials group and the assignment of studies to clinical research personnel within the group, and supervision of research staff. Plans and coordinates IRB submission, clinical trial plans and costing, strategies for increasing patient enrollment, improving efficiency, training of personnel, and identifying new research funding opportunities. 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
- 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 / IRB duties, budgeting duties, and assisting with patient research billing and reconciliation.
- 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.
- 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.
Qualifications
Qualifications:
- High School Diploma/GED required. Bachelor's or Master's Degree in Science, Sociology, Nursing or related degree preferred.
- 4 years of clinical research related experience required. 5-7 years of directly related experience strongly preferred
- No license or certification required. Certification in clinical research (SOCRA or ACRP) preferred.
About Us
About the Team
Req ID : 646
Working Title : Clinical Research Coordinator III - Guerin Children's - Pediatric Neurology/Neurosurgery (Full-Time, On-Site)
Department : Research - Peds General
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : EXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $71300 - $121000