Clinical Data Specialist

Job Description

Job Description

Celerion is committed to swift, exceptional clinical research through translational medicine.  Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.

Responsible for the review of all source data and ensure all applicable data is entered into its respective database and / or Case Report Form (CRF). Ensure the completeness, accuracy, and consistency of source data and CRF data entry so that it meets the standard of quality expected for reporting to Sponsors and regulatory bodies. Participate with auxiliary teams involved in study set up, conduct, and data cleaning of clinical trials.

Essential Functions

• 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

Requirements

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.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.