Clinical Research Associate I

Updated: 3 months ago
Location: Los Angeles, CALIFORNIA

Requisition # HRC0728129

Do you have a passion for the highest clinical quality and patient happiness? Would you like to use your expertise with an organization known nationally for excellence in cancer treatment, research and education? We would be happy to hear from you! Please consider the following exciting opportunity with one of the most outstanding and dynamic places to work in the medical field as your next career move.Summary of Essential Job

Job Summary:  Key Job Responsibilities
The Clinical Research Associate I works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study.  Evaluates and abstracts research data and ensures compliance with protocol and research objectives.  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.  Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.
Primary Duties and Responsibilities:
•    Works with a Clinical Research Coordinator, 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) including submission of 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.
Department-Specific Responsibilites
Additional primary duties and responsibilities that are only performed in the specific department(s) below:
Department    Duties and Responsibilities
Department Unit    Performs phlebotomy services according to CSMC policies and procedures. Verifies specimen identification, assesses appropriateness of test orders and quality of specimen by recognizing factors that affect procedures and results; takes appropriate action when corrections are indicated Identifies patients and patient samples by strict adherence to established procedures; labels samples accurately and completely. Reports test results to appropriate individuals and exercises professional discretion with patient information.


Educational Requirements
HS Diploma/GED

Experience:
No experience required

1 year clinical research experience preferred


  • Working Title: Clinical Research Associate I
  • 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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