Clinical Research Data Specialist II - Heart Institute- Ouyang

The Smidt Heart Institute reflects Cedars-Sinai's steadfast dedication to heart disease and research innovation giving patients access to the highest level of care. Year after year, thousands of people trust their hearts to Smidt Heart Institute at Cedars-Sinai. Our cardiologists, cardiac surgeons and specialized care teams treat the full spectrum of heart disease and disorders, while our investigators continue to advance the field with groundbreaking, life-saving research. From genetic counseling and targeted drug therapies to a growing array of minimally invasive procedures, Cedars-Sinai continues to stand at the forefront of technology, innovation and discovery improving patient outcomes.

Join our team and use your skill with an organization known nationally for excellence in research!

The Clinical Research 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.

Primary Duties and Responsibilities

• 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

Educational Requirements:

Requires a bachelor's degree or equivalent in education, training and experience.

Masters in Public Health preferred

Experience:
Two (2) years minimum experience in related field, or equivalent combination of education and experience.