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Clinical Research Associate II - Cancer Clinical Trials Office

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 - Cancer Clinical Trials Office 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 # HRC0438069A

Grow your career at Cedars-Sinai!

Cedars-Sinai Cancer is committed to pursuing pioneering research into disease mechanism, diagnostic innovations and new technologies and resources. Through our historic achievements, growing research enterprise, and serving one of the most diverse regions in the world, our physicians and scientists are uniquely positioned to guide the next generation of progress against the disease.

Join our team and use your expertise with an organization known nationally for excellence in cancer research.


The Clinical Research Associate II works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse 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, and assist with regulatory submissions to the IRB.  Provides limited patient contact as needed for study and assist with study budget and patient research 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.

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:

  • Works with a Clinical Research Coordinator or Research Program Administrator or Research Nurse to coordinate/implement study.
  • 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 patient contact or patient contact for long term follow-up patients 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.
  • Assists with patient research billing.
  • Schedules patients 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.
  • May 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.
  • May coordinate activities of other associates to ensure compliance with protocol and overall clinical research objectives. 
  • May have some percent of effort in centralized activities such as auditing, Standard Operating Procedure development, etc.
  • DEPARTMENT AND/OR UNIT SPECIFIC – ESSENTIAL JOB RESPONSIBILITIES:
    May work with the engagement lead, project lead, and study coordinators to assist the engagement team for the program.
  • May work remotely, on campus, and occasionally be asked to work off-site at events (under the supervision of study lead and/or study coordinators).
  • Attends weekly check-ins and team meetings.
    Interact with participants by answering and returning telephone calls, and answering participant questions.
  • May be responsible for the pick-up and delivery of clinical research-related items such as biospecimens.
  • May work with study coordinators and team to schedule patients for research visits and procedures.

 

Education:

  • BA/BS degree, required.

Licenses/Certifications:

  • ACRP/SoCRA (or equivalent) certification, preferred.

Experience:

  • Two (2) years of directly related clinical research experience, or equivalent combination of education and experience

 

  • Working Title: Clinical Research Associate II - Cancer Clinical Trials Office
  • Department: SOCCI Clinical Research Office
  • Business Entity: Academic / Research
  • City: Los Angeles
  • Job Category: 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

Discover all the ways Cedars-Sinai appreciates your efforts.

  • Healthcare

  • 401(K)/Retirement Plans

  • Continuing Education

  • Relocation Reimbursement

  • Professional Development

  • Work/life Balance

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