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
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What We Do
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
Why Work With Us
You will join a company which every colleague has the opportunity to create possibilities, for oneself, for our customers and patients. There is no more exciting place to be than at the forefront of solving problems which help improve lives around the world. As a company, we are committed to supporting your career aspirations and your journey.
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