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Clinical Research Data Coordinator II - Cancer Clinical Trials Office - Research Lab

Requisition # HRC0366320 Apply Now

The Cancer Clinical Trials Office (CCTO) staffed by highly trained professional research personnel (research nurses, clinical research coordinators and clinical research associates), is a central office that provides the infrastructure and function for operations of Cancer Clinical Trials at Cedars-Sinai Cancer (SOCCI), including its medical network and health system, which at any given time has approximately 140 cancer clinical trials. CCTO resources are available to both faculty and industry sponsors to assist throughout the lifecycle of a protocol, from inception to study closeout. We are the central point of contact who coordinates with investigational pharmacy, laboratory, nursing, the National Cancer Institute (NCI) and other collaborating academic institutions.

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

The Clinical Research Data Coordinator II for the CCTO Lab works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study.  The Clinical Research Data Coordinator II will work primarily in the Research Lab to assist with sample preparation, shipping, and maintenance of study supplies and kits for clinical trial protocols.  In Addition, this role may involve evaluation and abstraction of research data and data entry while ensuring 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.  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, Research Program Administrator or Research Nurse to coordinate/implement study.

  • Responsible for sample preparation, shipping and maintenance of study supplies and kits.

  • Assists with all lab duties to ensure proper conduct of clinical trial specimen processing.

  • Assists with preparation of laboratory manuals for Investigator Initiated studies.

  • Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.

  • Maintains all internal specimen processing tracking forms and spreadsheets including integration with OnCore.

  • Ensures compliance with protocol and overall clinical research objectives including reporting all deviations per protocol requirements.

  • Completes Case Report Forms (CRFs).

  • Assists with clinical trial budgets as related to laboratory specimen processing and laboratory supply cost.

  • Assists with patient research billing as it relates to specimens processed or analyzed within the CCTO laboratory.

  • Maintains schedule of patient visits and provides laboratory kits for phlebotomy laboratory.

  • 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.

 

Education:

BA/BS degree

 

Licenses/Certifications:

ACRP/SoCRA (or equivalent) certification preferred.

 

Experience:

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

 

  • Working Title: Clinical Research Data Coordinator II - Cancer Clinical Trials Office - Research Lab
  • 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
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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). 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 March each year) as a condition of employment, and annually thereafter as a condition of continued employment.

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Los Angeles, California

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