**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **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 Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.