Clinical Data Specialist
Job Posting for Clinical Data Specialist at Katalyst Healthcares & Life Sciences Inc
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.
Job Type: Full-time
Experience level:
- 4 years
Schedule:
- Day shift
Ability to Relocate:
- Irvine, CA: Relocate before starting work (Required)
Work Location: In person
Salary.com Estimation for Clinical Data Specialist in Irvine, CA
$86,492 to $114,006
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