Coordinate and facilitate the clinical trial data for participants enrolled in clinical research studies conducted by principal investigator(s) at University Hospitals Case Medical Center (20%)
Assist and complete case report forms entry, review and abstraction required to conduct clinical research with the IRB, pharmaceutical sponsor, and other internal/external agencies or committees (30%)
Provide timely and professional ongoing data entry of clinical trial data by identifying errors and inconsistencies of data in accordance with study submission/completion guidelines across a variety of studies in different therapeutic areas and phases (30%)
Assure that the integrity and quality of the clinical research trial is maintained and that the trial is conducted in accordance with SOPs, GCP guidelines, sponsor guidelines and current regulations (20%)
Perform other duties as assigned and comply with all policies and standards
Maintain and protect PHI according to UH policies and training
Requirements
High School Equivalent / GED (Required)
Detail-oriented with ability to work independently on multiple tasks and manage time effectively (Required proficiency)
Ability to understand and communicate data requirements to others (Required proficiency)
Medical terminology (Preferred proficiency)
Excellent verbal, written, interpersonal and written communication skills (Required proficiency)
Basic knowledge of computer operations and demonstrated computer skills in a variety of software environments (Excel, Access, Word, database applications) (Required proficiency)
Must abide by all requirements to safely and securely maintain Protected Health Information (PHI)
Ability to identify errors and inconsistencies in clinical trial data