Clinical Research Associate I - Spine Research - Department of Neurosurgery
Job Description
Join Cedars-Sinai and become part of a team that is at the forefront of medical advancements!
Work alongside physician-scientists and researchers who are making life-saving medical and scientific breakthroughs. Our team of scientists develop some of the most advanced clinical trials in the world.
About the Team
The research of Dr. Alexander Tuchman, MD is focused on outcomes for spine surgery patients, and treats adult patients with rare spinal conditions such as achondroplasia, a genetic condition that truncates the growth of the arms and legs and is the most common form of short-limbed dwarfism.
About the Role
The Clinical Research Associate I will work 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. The incumbent will support objectives of research studies through noncomplex tasks such as data collection, prescreening of and scheduling of current research participants, assisting in IRB submission activities, and budget and billing.
Primary Job Duties and 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).
- 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 attends meetings regarding study activity under the direction of supervising staff.
Department-Specific Duties:
- Transportation of research medications.
- Performs study related assessments and questionnaires.
- Maintains organized paper and electronic research files.
- Assists with preparing manuscripts, letters, and other research documents as needed.
- Performs literature reviews.
Education, Experience, and Skills:
- High School Diploma/GED is required.
- Clinical research experience is preferred.