Clinical Data Associate

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