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.
ESSENTIAL JOB 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.
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.
QualificationsEducational Requirements:
Requires a bachelor's degree or equivalent in education, training and experience.
Masters in Public Health preferred
Experience:
• Analyst experience preferred - Able to multitask in a diverse and demanding environment with frequently shifting priorities.
• Proactive, extremely organized and detail oriented.
• Strong record of interpersonal engagement.
• Able to demonstrate the ability to balance both working independently and collaboratively.
Physical Demands:
• Able to perform moderate lifting.
• Able to sit, stand and walk for prolonged periods of time.
• Able to read papers and online documents.
• Able to operate standard office equipment.
• Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.
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