Clinical Data Specialist

Celerion•Tempe, AZ

About The Position

Celerion is committed to conducting swift, exceptional clinical research through translational medicine. 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 for reporting to Sponsors and regulatory bodies. The specialist also participates with auxiliary teams involved in clinical-trial setup, conduct, and data cleaning.

Requirements

High school diploma or GED; relevant internal Celerion experience may be considered in lieu.
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

1–2 years of industry experience.
Previous quality-control, data-entry, or related experience.
Medical terminology training.

Responsibilities

Attend study setup meetings to determine quality-control criteria and timelines for each study.
Review study-specific source documents to ensure forms are accurate before study start and collected data conforms to study-specific Case Report Forms and protocol requirements.
Complete quality-control reviews according to study-specific timelines.
Review ongoing source data for completeness in accordance with GCP and FDA guidelines, documentation of protocol deviations when applicable, and compliance with Sponsor requirements and Celerion SOPs/PGs.
Ensure data corrections are completed according to GCP guidelines and Celerion SOPs/PGs.
Perform a final quality-control review to ensure all source data is accounted for and reviewed.
Perform accurate data entry and verification for Celerion Standard and Sponsor Provided EDCs.
Archive source documentation, including CRFs.
Complete dedicated quality-control/data-entry milestones in a timely manner.
Perform standard quality-control steps.