The Clinical Research Data Specialist II manages the 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. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
Primary Duties and Responsibilities- 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.
- BA/BS degree required
- Two (2) years minimum experience in related field, or equivalent combination of education and experience.
Req ID
: 1354
Working Title
: Clinical Research Clinical Research Data Specialist II, SPIN
Department
: Cancer - SOCCI Clinical Research
Business Entity
: Cedars-Sinai Medical Center
Job Category
: Academic / Research
Job Specialty
: Research Studies/ Clin Trial
Overtime Status
: EXEMPT
Primary Shift
: Day
Shift Duration
: 8 hour
Base Pay
: $31.13 - $52.92
Cedars-Sinai is an Equal Employment Opportunity 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 [email protected] 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. Cedars - Sinai's EEO and AA Policy Statement
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