Clinical Data Specialist

Attend study setup meetings to determine QC criteria and timelines for each study

Review study-specific source documents to ensure all forms are accurate prior to study start and that all data collected is in accordance with study-specific Case Report Forms and protocol requirements.

Ensure QC reviews are complete in accordance with study-specific timelines

Review source data on an ongoing basis to ensure the following: Clinical source data is complete according to GCP and FDA guidelines, protocol deviations (if applicable) are documented, and source data is collected in accordance with Sponsor requirements, and Celerion SOPs/PGs. Ensure data corrections are completed according to GCP guidelines, and Celerion SOPs/PGs. Complete a 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 QC/DE dedicated milestones in a timely manner

Perform standard quality control steps

Celerion Values: Integrity Trust Teamwork Respect

Are you ready to join our team?

Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.

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