Clinical Research Data Specialist I - Ouyang Lab

About the role

The Clinical Research Data Specialist I manages the data for assigned research studies. This includes designing forms for data collection, clinical data abstraction, processing data, maintaining record systems, and producing project reports for studies.

Responsibilities

• 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.
• Processes clinical data using a range of computer applications and database systems to support cleaning and management of subject or patient data.
• Designs forms for data collection and performs clinical data collection/abstraction.
• Produces project reports for research studies.
• Understands regulations, policies, protocols and procedures to control and maintain accurate records.
• 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.

Qualifications

• Education: Bachelor's degree in a relevant field (e.g., life sciences, health sciences) preferred.
• Experience: 1 year of experience in related field.
• Training in biostatistics, epidemiology, statistics, or a related field preferred.
• Analytical experience using Electronic Health Record (EHR) data, longitudinal data, and advanced clinical statistical models is preferred.