Clinical Research Data Specialist I, Clinical Trials (Hybrid)

Mobile

United States

Hybrid

USD 52,000 - 73,000

Full time

14 days+

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Job summary

University Hospitals Case Medical Center is seeking a Clinical Research Data Specialist I (Hybrid) to coordinate and manage data for participants enrolled in clinical studies. This role includes CRF entry, data review, and abstraction activities across multiple therapeutic areas and phases.

The position emphasizes timely data entry, data quality, and ensuring compliance with SOPs, GCP guidelines, and sponsor requirements, while maintaining confidentiality of PHI as part of standard procedures.

Qualifications

High School GED required.
Detail-oriented with ability to manage multiple tasks.
Strong ability to understand and communicate data requirements.
Excellent verbal and written communication skills.
Basic knowledge of computer operations with experience in Excel, Access and Word.

Responsibilities

Coordinate and facilitate clinical trial data for participants in University Hospitals Case Medical Center studies.
Assist with case report forms entry, review and abstraction for studies.
Provide timely data entry and identify errors per study guidelines across various trials.
Ensure trial data integrity and compliance with SOPs, GCP guidelines and sponsor requirements.

Skills

Detail-oriented

Data requirements communication

Verbal and written communication

Time management

Education

High School Equivalent / GED

Tools

Excel

Access

Word

Database applications

Job description

Clinical Research Data Specialist I, Clinical Trials (Hybrid) – (260008IB)

Description

What You Will Do

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 indifferent 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%)

Additional Responsibilities

Performs other duties as assigned.
Complies with all policies and standards.
For specific duties and responsibilities, refer to documentation provided by the department during orientation.
Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients. Annual training, the UH Code of Conduct and UH policies and procedures are in place to address appropriate use of PHI in the workplace.

Qualifications

Education

High School Equivalent / GED (Required)

Knowledge, Skills, & Abilities

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)
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 (ie Excel, Access, Word, database applications). (Required proficiency)

Physical Demands