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Form of workJob Description
Title: Clinical Trials Assistant
Reports To: Clinical Research Lead, Director, and Principal Investigator
Department: Clinical Research
FLSA: Non-Exempt (Hourly)
General Purpose of Job/Summary:
The Clinical Trials Assistant will assist the Clinical Research Coordinators (CRCs) with study coordination responsibilities for the Clinical Research department. Adhering to the ethics and standards of Good Clinical Practice certification is required.
Essential Duties and Responsibilities:
Understands and adheres to Good Clinical Practice (GCP), U.S. Food and Drug Administration (FDA), and Institutional Review Boards (IRB) guidelines
Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures
Assist with periodic review of study files for completeness
Assist CRCs with preparation, handling, and distribution of Clinical Trials Supplies and maintenance of tracking information
Assist with the tracking and management of Case Report Forms (CRFs), queries, and clinical data flow
Act as a central contact for the clinical team for designated project communications, correspondence, and associated documentation
May accompany CRCs to assist with clinical monitoring duties upon completion of required training
Maintains security and confidentiality of patients and study-specific information per protocols and applicable federal regulations
Performs other required duties as requested by the Clinical Research Lead, Director, or Principal Investigator
Education/Experience/Certifications
High School Graduate or equivalent required
College Graduate preferred
Current Good Clinical Practice certification required (must be obtained in the first 14 days after hire)
Technical Skills:
Intermediate computer skills: Microsoft Word, Outlook and Excel preferred
Intermediate clerical skills: typing, data entry, filing, and record keeping
