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
High School Diploma or GED (relevant internal Celerion experience in lieu preferred)
1 - 2 years industry experience preferred
Previous Quality Control/ Data Entry or related experience preferred
Medical Terminology Training preferred
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 required
Proficient in MS Office applications required
Excellent attention to detail skills required
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.