Regulatory Affairs Assistant

IQVIA•San Antonio, TX

1d•Onsite

About The Position

The Regulatory Affairs Assistant will facilitate document flow to ensure timely completion and distribution of study documents for all clinical trials at NEXT Oncology. This role involves managing regulatory files, coordinating site initiation visits, and ensuring compliance with study protocols and regulatory requirements. The position is office-based in San Antonio, Texas.

Requirements

Proficiency in Microsoft Word and Adobe Acrobat
Excellent verbal and written communication skills
Bachelors degree in administration or science, OR At least three-year experience in Regulatory Affairs in a research setting

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