Administration Support - Clinical Research

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Responsibilities

Job Summary:

Position provides support for clinical trials and activities in the maintenance of clinical research at Honor Health Research Institute. The position works closely with Research Coordination, Regulatory, and trial administration Staff to manage administrative activities, data management, and archiving activities as assigned. They will help transition paper records to online electronic binders in accordance with FDA Regulations, International Council of Harmonization, and Good Clinical Practices and manage the collection and distribution of performance metrics.
Essential

Functions
• Provides data management project support for clinical research trials in an activation stage and active stage, including patient pre‑screening for study eligibility, support for data submission and records clinical information in case report forms.
• Assists in the coordination and management of the CTMS to ensure trial activities are documented correctly and the finance team can bill promptly. Assists with subject follow‑up for assigned clinical protocols.
• Supports record archiving of documentation no longer needed for trial management, scans paper‑based binders and converts to electronic binders as assigned.
• Support the collection of data points for HRI2 processes and distribute to program management and HRI2 leadership for review and performance analysis.
• Maintains clear and regular communication with the Research Staff regarding project updates and assignments made. Provides input and assistance to the Research Staff in maintaining the Regulatory Binders for all ongoing research studies in accordance with FDA regulations and sponsor requirements. Maintains working relationships with external customers (e.g. professional research organizations and physicians) to facilitate the submission of clinical investigational material to the appropriate regulating body.

Performs other related duties as assigned.
Education
• Associate’s Degree – Preferred
• High School Diploma or GED – Required
Experience
• 1 year experience working with data information, administrative processes in a healthcare environment, or currently enrolled in a pre‑clinical academic program (pre‑med, pre‑nursing, core science major) – Preferred
• Other healthcare related field – Preferred
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