Work Schedule

Environmental Conditions

Job Description

Develops filing system for each study, to ensure each subject folder will be 
accessible to others if necessary. Ensures each folder is eventually complete and 
orderly with all required forms completed and audited for accuracy. Flags any 
discrepancies in data to be resolved by appropriate staff. Ensures proper 
documentation to the study file addressing any study issues so all aspects of the 
study are clear even years after study is completed.
Reviews protocol and case report forms (CRFs) to determine study specific 
information. Evaluates for gaps in information and discuss omissions with Team 
Leader and Project Manager to develop clear criteria for case report form 
completion.
Ensures accurate and timely completion of study CRFs to meet sponsor 
requirements and deadlines. Informs Research Team Leader and Project 
Manager of any issues/problems, which may cause delays.
Ensures principal investigator signs all CRFs and is apprised of any data issues 
on the study.
Ensure all study participants’ paperwork is complete and adequately reflects 
participation in the study as per FDA requirements. Boxes completed study 
information in accordance with the clinical archival process. Resolves any 
sponsor queries after the study has been completed.
Ensures all case report forms and subject folders are reviewed by QA prior to 
review by sponsor or signature by PI.
Sets up sponsor rooms prior to sponsor visit