Clinical Research Associate I / Certified Phlebotomy Technician (CPT) - Karsh Division of Gastroenterology & Hepatology - Per Diem (On-site)
About The Position
The research program of Ju Dong Yang, MD, has been focused on clinical and translational research of liver cancer. Dr. Yang conducted several population-based cohort studies to describe recent trends in liver cancer epidemiology in the United States. He published several outcome research papers in liver cancer. Dr. Yang has also conducted several modeling studies and proposed a survival prediction model in liver cancer patients. The Clinical Research Associate I works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies. Supports objectives of research studies through noncomplex tasks such as data collection, prescreening and scheduling of current research participants, assisting in IRB submission activities, budget and billing, and ensuring overall compliance with all federal and local guidelines.
Requirements
- High School Diploma or G.E.D. is required.
- California Certified Phlebotomy Technician I or Certified Phlebotomy Technician II certification is required.
- Clinical Research experience is highly preferred.
- Understanding of general research objectives.
Nice To Haves
- Bachelor's degree in Science, Sociology, or related degree, preferred.
- ACRP/SoCRA certification is preferred.
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 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.
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What This Job Offers
Career Level
Entry Level
Education Level
High school or GED
