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Clinical Research Associate II - Al-Louzi Lab - Neurology

Los Angeles, California

Overview

Cedars-Sinai is a hub for biomedical research and a training center for future physicians and other healthcare professionals. By joining us in an academic role, you’ll be a part of formulating future ideas for discovery and then translating those discoveries into cures for the benefit and health of the Los Angeles community.

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Success Profile

What makes a successful Clinical Research Associate II - Al-Louzi Lab - Neurology at Cedars-Sinai? Check out the traits we’re looking for and see if you have the right mix.

  • Analytical
  • Organized
  • Deadline-oriented
  • Adaptable
  • Results-driven
  • Problem-solver

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Culture

Discovery is central to Cedars-Sinai’s mission. Our laboratories and clinics generate ideas, therapies, devices, and systems that contribute to biomedical progress around the world. Cedars-Sinai’s investigators push the frontiers of biomedicine with studies in cardiac care, cancer, digestive health, the neurosciences, women’s health, and more. Cedars-Sinai’s robust academic enterprise shapes the experts who will help redefine medicine for the next generation.

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Responsibilities

Requisition # HRC0980014

When the work you do every single day has a crucial impact on the lives of others, every effort, every detail, and every second matters. This shared culture of happiness, passion, and dedication pulses through Cedars-Sinai.

The Clinical Research Associate II works directly with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate and/or implement the study and may serve as the point of contact for the external sponsors. This role evaluates and abstracts research data and ensures compliance with protocol and research objectives. Position is responsible for completing case report forms, entering clinical research data, assisting with regulatory submissions to the IRB, provides limited contact with research participants as needed for study, and assists with study budget and research participant billing. In addition, the CRA II may coordinate activities, training, and education for other Clinical Research Associates. This role will comply with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.

The candidate will work directly with and under the supervision of Dr. Al-Louzi in the Visual Outcomes Laboratory. The project will involve exciting aspects of investigating visual function data, obtaining high-resolution retinal and magnetic resonance imaging as part of clinical studies aimed at understanding the interplay between visual disability and CNS injury in neuroimmunological disorders and Multiple Sclerosis (MS). Time will be split between organizing clinical research visits, performing retinal imaging using an optical coherence tomography (OCT) scanner, visual function testing, as well as participating in research projects using state-of-the-art magnetic resonance imaging (MRI) techniques. The prospective candidate will be responsible for scheduling research visits, attending consenting procedures, obtaining standardized measures of disability and visual outcomes, completing Case Report Forms (CRFs), and helping with organization and data entry into a clinical research database. Incumbent will be expected to assist with research billing, research budgets, regulatory submissions to the IRB, data analysis, and manuscript preparation.

Primary Duties and Responsibilities:

  • Evaluates and abstracts clinical research data from source documents.
  • Ensures compliance with protocol and overall clinical research objectives.
  • Completes Case Report Forms (CRFs).
  • Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
  • Provides supervised contact with research participants or contact for long term follow-up research participants only.
  • Assists with regulatory submissions to the Institutional Review Board (IRB) and works closely with supervising research staff or directly with the Institutional Review Board to submit Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
  • Assists with clinical trial budgets and patient research billing.
  • Schedules research participants for research visits and research procedures.
  • Responsible for sample preparation and shipping and maintenance of study supplies and kits.
  • 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.
  • Serve as the point of contact for external sponsors for select trials. 
  • May participate in the development of Investigator Initiated trials for Investigational New Drug applications and/or Device applications. 
  • May be involved in training and education of other Clinical Research Associates. 
  • Coordinates activities of other associates to ensure compliance with protocol and overall clinical research objectives. 

 

 


Education:

  • High School Diploma or G.E.D. is required.
  • BA/BS degree is preferred.

Licenses: 

  • ACRP/SoCRA (or equivalent) certification preferred.

Experience: 

  • One year of directly related experience is required.  Two years of relevant experience is highly preferred.
  • Ability to work in the clinical environment is essential.  
  • Previous experience with acquisition, post-processing, or interpretation of magnetic resonance imaging (MRI) or optical coherence tomography (OCT) scans preferred but not required. 

Physical Demands:

Able to perform moderate lifting. Able to sit, stand and walk for prolonged periods of time. Able to read papers and online documents. Able to operate standard office equipment. Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.


Working Title:Clinical Research Associate II - Al-Louzi Lab - Neurology
Department:Neurology Dept
Business Entity:Academic / Research
Job Category:,Academic/Research,Academic/Research
Job Specialty:Research Studies/Clinical Trials
Position Type:Full-time
Shift Length:8 hour shift
Shift Type:Day

Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law. If you need a reasonable accommodation for any part of the employment process, please contact us by email at Applicant_Accommodation@cshs.org and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

Cedars-Sinai will consider for employment qualified applicants with criminal histories, in accordance with the Los Angeles Fair Chance Initiative for Hiring.

At Cedars-Sinai, we are dedicated to the safety, health and wellbeing of our patients and employees. This includes protecting our patients from communicable diseases, such as influenza (flu) and COVID-19. For this reason, we require that all new employees receive a flu vaccine based on the seasonal availability of flu vaccine (typically during September through April each year) as a condition of employment, and annually thereafter as a condition of continued employment, subject to medical exemption or religious accommodation. For the same reason, you may also be required to receive other vaccines such as COVID-19 as a condition of employment. Cedars-Sinai reserves the right to make modifications to its required list of vaccines as required by law and/or policy.

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Rewards

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  • Healthcare

  • 401(K)/Retirement Plans

  • Continuing Education

  • Relocation Reimbursement

  • Professional Development

  • Work/life Balance

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