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GI Alliance · 4 days ago

Clinical Regulatory Assistant

Gurnee, IL

Full-time

Hybrid

Entry Level

1+ years exp

GI Alliance is seeking an experienced Clinical Regulatory Assistant. The primary responsibility of the Clinical Regulatory Assistant is to assist the Clinical Regulatory Supervisor with conduct and compliance of research studies, supporting daily clinical trial activities.

Health CareMedical

Responsibilities

Compiles and collects required compliance training documents

Uploads files and routes documents for signature from GI Alliance Research personnel

Maintain and utilize interim regulatory reports to ensure accurate documentation is being retained

Compile and prepare materials for submission to regulatory agencies

Review clinical protocols to ensure collection of data needed for regulatory submissions

Participate in internal or external audits

Identify relevant guidance documents

Occasional travel to other GI Alliance Research clinics

Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines

Assists Study Team, as needed in communication of study requirements to all individuals involved in the study

Maintains the integrity of assigned electronic files in Clinical Trial Management System

Assists Study Team in completing study documentation and maintenance of study files in accordance with sponsor requirements and GI Alliance Research policies and procedures including, but not limited to, study protocols, financial disclosure forms, FDA 1572 forms, study site logs and other essential documents

Aids the Study Team in maintaining effective and ongoing communication with sponsor, research participants, Director and PI during the course of the study

Works with the Study Team to manage the day to day activities of the study including problem solving and communication

Arranges secure storage of study documents that will be maintained according to Good Clinical Practice guidelines or for the contracted length of time, whichever is longer

Assists Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations

Cooperates with GI Alliance Research compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance to the appropriate compliance office

Other duties as assigned