The Clinical Research Data Specialist I manages and processes clinical research data for assigned studies, ensuring data accuracy, integrity, and compliance with regulatory bodies such as the FDA and Institutional Review Boards. Responsibilities include designing data collection forms, abstracting clinical data, maintaining large computerized records, and producing project reports, while adhering to Good Clinical Practice guidelines and HIPAA regulations. This role supports biomedical research efforts by maintaining meticulous data systems that facilitate advanced medical discoveries at the Heart Institute.
Job DescriptionEveryone’s unique health journey is informed by data. Join us as we translate today's discoveries into tomorrow's medicine.
Cedars-Sinai is home to some of the most advanced biomedical research and training programs in the world, which attracts renowned physician-scientists seeking an unparalleled environment for fostering invention and teamwork.
Research | Cedars-Sinai
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.
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:
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.
QualificationsEducational Requirements:
Requires a bachelor's degree or equivalent in education, training and experience.
Masters in Public Health preferred
Experience:
• Able to multitask in a diverse and demanding environment with frequently shifting priorities.
• Proactive, extremely organized and detail oriented.
• Strong record of interpersonal engagement.
• Able to demonstrate the ability to balance both working independently and collaboratively.
Analyst experience preferred
Physical Demands:
• 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.
clinical research data, data abstraction, Good Clinical Practice, FDA compliance, HIPAA, biomedical research, data management, clinical trials, reporting, health information
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