Clinical Research Data Specialist I, Clinical Trials (Hybrid)

University Hospitals • Cleveland, OH

1d • Hybrid

About The Position

This role involves coordinating and facilitating clinical trial data for participants in research studies conducted by principal investigators at University Hospitals Case Medical Center. The specialist will be responsible for entering, reviewing, and abstracting case report forms, ensuring data integrity and quality in accordance with SOPs, GCP guidelines, sponsor guidelines, and current regulations. This position requires meticulous attention to detail, the ability to work independently, and strong communication skills to manage data requirements and identify errors or inconsistencies across various studies and therapeutic areas.

Requirements

• High School Equivalent / GED (Required)
• Detail-oriented person with the ability to work independently on multiple tasks and manage time effectively. (Required proficiency)
• Ability to understand and communicate data requirements to others. (Required 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 (ie Excel, Access, Word, database applications). (Required proficiency)

Nice To Haves

• Medical terminology (Preferred proficiency)

Responsibilities

• 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.
• 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.
• 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 indifferent therapeutic areas and phases.
• 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.
• Performs other duties as assigned.
• Complies with all policies and standards.
• Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED