Job Posting: 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.
Qualification Requirements/Preferences: 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 Certification/License: ACRP/SoCRA (or equivalent) certification preferred. Experience: 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.
Providing healthcare for more than 100 years, Cedars-Sinai has evolved into one of the most dynamic and highly renowned medical centers in the world. Along with caring for patients, Cedars-Sinai is a hub for biomedical research and a training center for future physicians and other healthcare professionals. This attracts exceptional talent to Cedars-Sinai, including world-renowned physician-scientists who seek a place where they can both conduct research and see patients--the ideal formula for discovery and its translation into cures. Our patients benefit from access to doctors at the top of their fields, and our researchers have an ideal community in which to study the impact of healthcare challenges, and reflect that knowledge in their research. The greater Los Angeles area in which Cedars-Sinai resides possesses unparalleled cultural and ethnic diversity which offers outstanding opportunities for translational and clinical research and a dynamic environment for medical education.Although community based, Cedars-Sinai is a major teaching hospital affiliated with the David Geffen School of Medicine at the University of California, Los Angeles (UCLA). Cedars-Sinai has highly comp...etitive graduate medical education programs in more than 50 specialty and subspecialty areas, a graduate program in biomedical sciences and translational medicine, a clinical scholars program directed towards junior physicians with aspirations to become clinical scientists, and post graduate training opportunities.There are more than 250 full-time faculty members at Cedars-Sinai. The voluntary medical staff, comprised of more than 2,200 specialty board-certified or board-qualified physicians, represent all of the specialties and subspecialties and collaborate with full-time medical staff in the teaching responsibilities of the graduate medical education programs.