Clinical Data Coordinator
On-site · Minneapolis, Minnesota, United States
Job Summary
Clinical Data Coordinator role focusing on end-to-end data management in clinical studies. Responsibilities include CRF/edit check development, data management plans, data snapshots, data quality reviews, and escalation of data issues identified in study databases and DM reports. Requires extensive knowledge of the clinical study lifecycle and GCP, ability to work independently to ensure on-time delivery of DM deliverables, and experience testing clinical databases, edit checks, and study reports. Desired skills include familiarity with 21 CFR Part 11, HIPAA, Oracle Clinical, and general DM applications, plus strong communication, prioritization, and teamwork capabilities. Local Minneapolis, MN candidate required; Bachelor’s Degree is mandatory.
Required Qualifications
- Bachelor's Degree
- Experience in clinical data management applications (e.g. Oracle Clinical)
- Knowledge of Good Clinical Practices (GCP)
- Knowledge of FDA 21 CFR Part 11 regulation
- Knowledge of HIPAA
- Ability to identify data-related issues using study databases and DM reports
- Strong communication skills
- Ability to prioritize tasks and manage competing priorities
- Independent work capability
- Proficiency with Microsoft Office
Additional Requirements
- Local candidate required in Minneapolis, MN, USA
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