Job Posting: Summary of Essential Job Duties: The Clinical Research Data Specialist I 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. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board. 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. The Posadas Laboratory is a translational research center focused on advanced prostate cancer and the biology of metastasis. This laboratory is part of a network of labs within the Uro-Oncology research program at Cedars-Sinai. Moreover, the laboratory is integrated into the Urologic Oncology Program clinics. This position entails creation and maintenance of databases with clinical information (both identifiable and de-identified) with research samples. The candidate will also be working with the clinical team to facilitate data entry for ongoing clinical trials. Requires skill in designing, altering, and maintaining databases in FileMaker Pro. Data entry will occur, not only in FileMaker Pro but also in multiple other platforms (including REDCap). Position is also responsible for completing case report forms, entering clinical research data. Works with a clinical and laboratory teams to develop and maintain databases essential to clinical research operations; these will include data from clinical sources such as hospital records, patient charts, lab reports, and electronic medical record systems. Creates new databases and improves/maintains/updates existing databases including: ensures a system of data and database version control, queries and cleans data, outlines methods for quality assurance and control, develops and maintains the data manual and data dictionary, maintains and checks security/access features, creates datafiles for data export for analysis. May aid with shipping and maintenance of research specimens. Will need to meet institutional requirements for handling clinical data as required by Institutional Review Board (IRB) and Clinical Research Office (CRO). Educational Requirements: BA/BS or equivalent combination of education and experience. License/Certification/Registration Requirements: ACRP/SoCRA (or equivalent) certification preferred. Experience: Must have experience with FileMaker Database creation and maintenance on the FileMaker Server Platform. Data Management and Data Entry experience in clinical research will be strongly considered. Experience in oncology data entry will be strongly considered Physical Demands: (e.g., lifting, standing, walking) 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. EEO / AA / F / M / Veteran / Disabled Cedars-Sinai will consider for employment qualified applicants with criminal histories, in accord
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-scien...tists 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 competitive 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.