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The research focus of Dr. Shlomo Melmed is molecular pathogenesis of pituitary tumors and pituitary receptor signaling. The Ruf-Zamojski Lab focuses on understanding the mechanisms of gene regulation and epigenetic circuits that underlie cell states and fates, as well as their variation in health and disease.

About the Role

The Clinical Research Data Specialist II independently manages data for assigned research studies, demonstrating a high level of expertise and autonomy. This will include, designing forms for data collection, clinical data abstraction, processing data, maintaining record systems, and producing project reports for studies. The Specialist also trains clinical research staff, perform basic statistical analysis, and collaborates with bioinformatics to develop and maintain trial management systems. The incumbent ensures compliance with all federal and local agencies, including the Food and Drug Administration (FDA) and local Institutional Review Board.

Primary Duties and Responsibilities:

• Collaborates with bioinformatics in the development and maintenance of clinical trials management systems including validation of systems.
• Prepares project reports and performs statistical analysis in conjunction with a biostatistician, interpreting and presenting findings to support study objectives and data quality initiatives.
• Trains clinical research staff on data collection standards, protocol requirements, and data entry systems to promote accuracy and consistency in research data.
• Identifies and resolves operational/data problems, recommending and implementing process improvement with minimal supervision.
• Configures a range of computer applications and database systems to process clinical data in support of cleaning and management of subject or patient data.
• Independently manages and maintains research data to ensure accuracy, integrity, and security of complex, large computerized records systems. This includes performing data searches and other related administrative tasks.
• Performs clinical data collection, abstraction, targeted data searches to support accurate and timely data availability for study objectives.
• Understands regulations, policies, protocols and procedures to control and maintain accurate records.
• 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.

Please note that this is a one-year fixed term part-time position eligible for benefits.

Education:

• Bachelor's degree in a related field of research is required.

Experience:

• 2 years of experience in a related field of research is required.