Cedars-Sinai Clinical Research Data Specialist II in Los Angeles, California
Clinical Research Data Specialist II Requisition # 29889
The Clinical 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.
This position will support secondary analyses to understand the incidence and outcomes of gastrointestinal cancers. Data sources include electronic health records, Medical claims files, and Tumor Registries. Extracts health-related data from a clinical data warehouse and Medical claims files.
Organizes the extracted data into a curated dataset and checks for quality and integrity of data and documents the data collection process.
Works with longitudinal data to determine the timing of onset of medical conditions and to chart change in continuous health measures (e.g. weight).
Integrates medical records data with incidence cancer data from tumor registries. Creates flowcharts for selection of patients.
Maintains meticulous programming codes (SQL, SAS). Performs literature review for identifying appropriate EHR-based definitions for covariates.
Other Job Duties and Responsbilities:
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.
Education Certifications/Licensure Experience Physical Abilities Education:
BA/BS degree required. Preferred Masters degree in a quantitative science preferred (Epidemiology, Statistics, Mathematics or Engineering preferred.
SQL and SAS experience strongly recommended
Experienced in managing relational data from hospitals, pharmaceutical databases or health insurance databases
ACRP/SoCRA (or equivalent) certification preferred.
Two (2) years minimum experience in related field, or equivalent combination of education and experience.
Physical Requirements (physical abilities essential to perform the job)
Able to perform moderate lifting. Able to sit, stand and walk for prolonged periods of time. Able to read papers and online documents. Able to operate standard office equipment. Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.
- Working Title: Clinical Research Data Specialist II
- Business Entity: CSMC - Cedars-Sinai Medical Center
- Cost Center # - Cost Center Name: 0879006 - SOCCI Clinical Research Office
- City: Los Angeles
- Job Category: Research/Research Admin
- Job Specialty: Clinical Research
- Position Type: Regular-F/T
- Shift Length: 8hr
- Hours: 9am - 5pm
- Days: Monday - Friday
- Shift Type: Day
- Weekends: None
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.