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Clinical Research Data Specialist II - Sponsor- Investigator Support Unit - Cancer

Requisition # HRC0390201 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, 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 Specialist II - Sponsor-Investigator Support Unit will manage data for assigned research studies. This will include, designing forms for data collection, clinical data abstraction, processing data, maintaining record systems, and producing project reports for studies. In addition, may train clinical research staff, perform basic statistical analysis, and work with bioinformatics to develop and maintain trial management systems.

In addition, the Clinical Research Data Specialist II - Sponsor-Investigator Support Unit will be responsible for the following:

  • Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
  • May work with bioinformatics in the development and maintenance of clinical trials management systems including validation of systems.
  • May train clinical research staff to help improve the quality of the data being collected.
  • May solve operational/data problems in consultation with other employees and/or supervisors. May perform basic statistical analysis in conjunction with a biostatistician.
  • Manages data for research studies. Designs forms for data collection.
  • Performs clinical data collection/abstraction.
  • Processes clinical data using a range of computer applications and database systems to support cleaning and management of subject or patient data.
  • Produces project reports.
  • Maintains the accuracy, integrity and security of complex, large computerized records systems. Understands regulations, policies, protocols and procedures to control and maintain accurate records. Performs data searches and other related administrative tasks.
  • 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.
  • Performs study-specific planning and design of data collection by consulting with PIs, biostatistician, and study team to determine project requirements to determine data to be collected and appropriate data resources for specific oncology clinical research trials
  • In collaboration with the PI and study team, formulate data management plans
  • Develop and implement evaluation methodology to determine completeness and adequacy of data collection procedures
  • Understand and ensure privacy law and standards, and other applications of GCP to Data Management
  • Implement timely database development and management of database by developing, testing and validating electronic Case Report Forms
  • Provide quality oversight of data collection and analysis by reviewing protocol and applying protocol-specified guidelines to the review and cleaning of clinical data
  • Program edit checks to query discrepant data and perform validation checks to ensure completeness and consistency of data
  • Issue queries to resolve errors and missing data in a timely manner
  • Perform and document procedures for data preparation including data cleaning, standardization and analysis
  • Deliver completed datasets to investigators for abstracts and manuscripts, or other applicable projects that require the data
  • Provide access and train users to EDC for IITs
  • Assist in management of the day-to-day operations and system applications associated with Clinical Trials.gov (CTG) reporting
  • Reviews new and ongoing studies and abstracts relevant information to enter into CTG
  • Collaborates with PIs and statisticians to monitor timely analysis and reporting of results for CTG per required timeframes
  • May assist in registration and/or maintenance of Clinical Trials Reporting Program (CTRP)
  • Perform other related duties as assigned or directed by Leadership to meet the goals and objectives of the CCTO

Educational Requirements:

  • BA/BS degree.

License/Certification/Registration Requirements:

  • ACRP/SoCRA (or equivalent) certification preferred.

Experience:

  • Four (4) years of experience supporting Sponsor/Investigator trials, required.
  • Knowledge and experience usding REDCap, required.
  • Demonstrated experience performing study-specific planning and design of data collection in collaboration with the study PI, biostatisticians and team, strongly preferred.
  • Working Title: Clinical Research Data Specialist II - Sponsor- Investigator Support Unit - Cancer
  • Department: SOCCI Clinical Research Office
  • Business Entity: Academic / Research
  • City: Beverly Hills
  • Job Category: Information Technology
  • Job Specialty: Business Systems & System Analysis
  • 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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