Clinical Research Associate I - CSF Leak Research Program - Department of Neurology
Cedars-Sinai
Clinical Research Associate I - CSF Leak Research Program - Department of Neurology
Cedars-Sinai
Posted 3 months ago
Full Time
Los Angeles, California
In Person
Smart Summary
Responsibilities
Assist in the coordination and implementation of noncomplex research studies through data collection and participant scheduling. Support regulatory activities including IRB submissions, budget tracking, and sample maintenance.
Qualifications
You have experience collecting and abstracting clinical research data, entering it into Electronic Data Systems (EDCs), and completing Case Report Forms (CRFs). You are capable of assisting with regulatory submissions to the Institutional Review Board (IRB), including Adverse Events, and maintaining patient confidentiality per HIPAA regulations.
Must Have Skills for ATS
Electronic Data Systems (EDCs)
Case Report Forms (CRFs)
Institutional Review Board (IRB)
HIPAA
Good Clinical Practice (GCP)
FDA
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 Wouter I Schievink, MD, focuses on outcomes of complex cerebrovascular surgery, syndromes of spontaneous intracranial hypotension/spinal CSF leaks, as well as extracellular matrix proteins in intracranial aneurysms and cervicocephalic arterial dissections and models of intracranial aneurysms.
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.
Cedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents.
Cedars-Sinai is one of the largest nonprofit academic medical centers in the U.S., with 886 licensed beds, 2,100 physicians, 2,800 nurses and thousands of other healthcare professionals and staff. Choose this if you want to work in a fast-paced environment that offers the highest level of care to people in the Los Angeles that need our care the most.
Cedars-Sinai
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