Clinical Research Data Specialist I

Job Description

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 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

High school diploma or GED required; BA/BS in a related field preferred.

Work Experience

1 year of experience related to the field of research required.