Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Under the general direction of the Clin Ops Supervisor, the CDA is responsible for the successful completion and filing of case report forms and source documents for clinical research studies. Works with sponsor representatives at all meetings/visits when case report form data is reviewed. Ensures all subject data is boxed as required for study archiving.
Essential Functions and Other Job Information:
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 Clin Ops Supervisor and Clinical Research 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 Clin Ops Supervisor and Clinical Research 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 visi
