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IQVIA · 1 day ago

Regulatory Affairs Assistant

Arlington, VA

Full-time

Onsite

Entry Level

3+ years exp

IQVIA is a leading global provider of clinical research services, and they are seeking a Regulatory Affairs Assistant to facilitate document flow for clinical trials at NEXT Oncology. The role involves maintaining regulatory files, distributing study documents, and providing administrative support to ensure compliance and efficiency in clinical research operations.

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Responsibilities

Give tours of NEXT Oncology to clinical trial Sponsors and other visitors as applicable

Complete feasibility questionnaires for proposed clinical trials as needed

Set up Site Initiation Visits and other meetings as needed

Enter study-specific information (such as but not limited to, study title, assigned staff, documents received from Sponsor, IRB submission/approval dates, etc.) in internal FileMaker database to provide a complete history of each clinical trial

Maintain official regulatory files in our electronic regulatory files system (eDOCS) for clinical trials being conducted at NEXT Oncology once a study is approved by the IRB

Distribute new or updated study documents to appropriate staff when received

Distribute IRB review/approval documents to appropriate study members (internal and external) within 24-hours from IRB receipt

Set up access for NEXT Oncology staff in eDOCS to ensure most current documents are available to all staff

Set up access for Sponsors and their representatives in eDOCS once the Site Initiation Visit has occurred

Complete various documents (such as but not limited to: Delegation of Authority Logs, Form FDA 1572s, Financial Disclosure Forms, etc.) for clinical studies being conducted at NEXT Oncology

Maintain current CVs and Medical Licenses for investigators

Maintain current training documents (GCP, HRS, etc.) in eDOCS for all NEXT Oncology staff

Receive incoming correspondence/files and review/forward to appropriate staff

Attend Phase I meetings, Site Initiation Visit meetings, and other meetings as applicable

Perform a variety of administrative duties including but not limited to: answering phones; faxing and filing of confidential documents; and basic Internet and email utilization

Provide excellent customer service to all internal and external customers