Clinical Research Associate II

External Description

Seattle Children's has multiple openings for an experienced clinical research professional!  Collaborate with members of the assigned division research team in the organization, implementation and coordination of clinical research trials including: collection and management of source documents and study records while ensuring data collection is timely, standardized and accurate and meets sponsor/FDA/Children’s standards, management of data queries, ensuring protocol adherence and patient study eligibility across a multi-disciplinary team, assist in monitoring and reporting of AEs/SAEs/protocol deviations, ensure specimens/tests/procedures are obtained/conducted per protocol.

 

Create and maintain regulatory documents; organize protocol implementation and site initiation visits; and conduct routine internal monitoring of clinical studies.

 

Ensure that research projects are conducted in compliance with federal regulations, institutional/departmental guidelines and standards of Good Clinical Practice.

Requirements

Required Education/Experience:
- Bachelor’s Degree in Social Studies, Biology, or related scientific discipline, or equivalent combination of education and experience.
- Minimum of three (3) years of related research experience.

Preferred:
- Master’s Degree in a scientific discipline or related field
- CCRA certification/CCRP certification
- Database management skills

- Experience utilizing CTMS and EDCs
- Pediatric research experience

- Hem/Onc clinical research experience

- Knowledge of GCP, FDA, ICH guidelines

- Able to work under pressure with tight timelines

- Able to work collaboratively in a team environment


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