Clinical Data Specialist

Celerion • Tempe, AZ

4d

About The Position

Celerion is committed to swift, exceptional clinical research through translational medicine, using its experience, agility, and innovative research strategies to help get drugs to market faster. The Clinical Data Specialist reviews source data and ensures applicable data is entered into the appropriate database and/or Case Report Form (CRF). The role ensures source data and CRF entries are complete, accurate, and consistent, meeting the quality standards expected by sponsors and regulatory bodies. The specialist also participates with auxiliary teams involved in clinical study setup, conduct, and data cleaning.

Requirements

• High school diploma or GED; relevant internal Celerion experience may be considered in lieu of this requirement.
• Excellent oral and written communication skills.
• Ability to organize and manage multiple priorities.
• Experience working in an environment with complex processes and defined criteria.
• Excellent time management skills.
• Proficiency in MS Office applications.
• Excellent attention to detail.

Nice To Haves

• One to two years of industry experience preferred.
• Previous quality control, data entry, or related experience preferred.
• Medical terminology training preferred.

Responsibilities

• Attend study setup meetings to determine study-specific quality control criteria and timelines.
• Review study-specific source documents to ensure forms are accurate before study start and data collection follows study-specific CRFs and protocol requirements.
• Complete QC reviews in accordance with study-specific timelines.
• Review source data on an ongoing basis for completeness under GCP and FDA guidelines, documentation of protocol deviations where applicable, and compliance with sponsor requirements and Celerion SOPs/PGs.
• Ensure data corrections are completed according to GCP guidelines and Celerion SOPs/PGs.
• Complete final QC to ensure all source data is accounted for and has been QC reviewed.
• Perform accurate data entry and verification for Celerion Standard and sponsor-provided EDCs.
• Archive source documentation, including CRFs.
• Complete dedicated QC/DE milestones in a timely manner.
• Perform standard quality control steps.

What This Job Offers

• Job Type: Full-time
• Education Level: High school or GED