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Dr. Ouyang and his clinical research team is seeking a highly motivated Clinical Research Data Specialist I to join their team.
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.
Primary 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.
- 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.
Education :
Minimum of a Bachelor of Science or Bachelor of Arts degree required.
Experience and Skillset :
- One (1) year of experience in related field, preferred.
- Experience with data analysis and coding using R is highly desired.
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