Clinical Data Coordinator Trainee

Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com.

The Clinical Data Coordinator (CDC) is a key member of the Clinical Development Operations, Data Management Team. The Clinical Data Coordinator will provide data management support for all assigned studies. The CDC Prepares, validates, processes, and maintains clinical data in support of submissions to international regulatory agencies or publication of manuscripts. This will be accomplished with through the use of EDC and SAS software.

• Assists in the development of edit specifications, based on any available global medical standards, therapeutic area standards, and the protocol, used to clean the study.
• Supports the coding schedule defined in the data management plan.
• Performs manual data listing reviews and submits queries as appropriate.
• Assists in determining when each patient has no more data quality issues, based on EDC, coding, and SAS based queries. Also, must coordinate and review medical and statistical queries and certify they are adequately resolved.
• Coordinates the query management system functions.
• Assists in performing final patient reviews and database lock activities.
• Assists in coordinating the processing of scheduled data transfers (PK / PD data, imaging data, laboratory data) from external vendors
• Performs relevant review / reconciliation of 3rd party data.
• Reviews query responses and ensures data quality.
• May draft or update documents for the data management plan.
• May assist with the SAE reconciliation process.

Education : Bachelor's degree in related discipline and one year of related experience; or high school diploma.

Required Skills

Skills Required

EDC, Sas, Microsoft Office Suite