The Clinical Research Data Associate 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.

Principal Responsibilities:

• Coordinates 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.
• Performs data searches and other related administrative tasks
• Participates in required training and education programs.
• Works closely with study monitors to review study data and respond to inquiries.
• Provides support and preparation for study audits.
• 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.
• Responds timely, effectively and appropriately to deliverables
• Shares knowledge, time and expertise to assist other members of the team
• Establishes effective working relationships with cross-functional team(s)

• High School Diploma/GED, (Minimum)
• Bachelor's Degree, BA/BS degree in science or science related field. (Preferred)
• Two (2) years minimum experience in related field (Minimum)
• Certification In Clinical Research ACRP/SoCRA (or equivalent) certification.(Preferred)