clinical data manager Orlando, FL
Job description
Job Description
Under the general direction of the Research Team Leader, the Research Team 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.
- 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.
