Clinical Data Specialist
Job Details
Irvine, California, United States
Katalyst Healthcares & Life Sciences
Posted today
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Full Job Description
Responsibilities:Independently ensure all study data is validated in accordance with regional and federal clinical study guidelines.
Oversee database design, testing, and optimization.
Create and implement clinical trial methods for collecting and analyzing site- and patient-specific clinical trial data.
Create and maintain SOWs (contracts) and oversee invoicing.
Perform literature searches and conduct outcomes research and economic modeling projects.
Manage PubStrat publication management system and approval process.
Support EOS copy review process including submittals for review and reference annotation process.
Act as department Training Coordinator for Compliance Wire.
Manage approvals for master service agreements, work proposals, and other contracts with Legal and third-party consultants.
Manage Totality HCC approval process.
Responsible for communicating business related issues or opportunities to next management level.
Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
Performs other duties assigned as needed.
Requirements:
BA/BS in Biology is highly preferred
Good organizational and math skills
Must be able to prioritize and make quick decisions
Knowledge of data collection practices and Medical Terminology
Knowledge of Good Research Principles
Ability to work under deadlines in a fast-paced work environment
Computer literacy required in Microsoft Office such as Word, Excel and Outlook
Prior knowledge of electrophysiology is preferred, but not required
This position may require work in clinical and/or laboratory environments.
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Clinical Data Specialist
Katalyst Healthcares & Life Sciences
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