Regulatory Affairs Assistant
IQVIA
full-time
Posted on:
Location Type: Office
Location: San Antonio • Texas • United States
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About the role
- Facilitate document flow to ensure timely completion and distribution of study documents for all clinical trials at NEXT Oncology
- 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 in internal FileMaker database
- Maintain official regulatory files in electronic regulatory files system (eDOCS)
- Distribute new or updated study documents to appropriate staff when received
- Distribute IRB review/approval documents to appropriate study members within 24-hours from IRB receipt
- Set up access for NEXT Oncology staff and Sponsors in eDOCS
- Complete various documents for clinical studies being conducted at NEXT Oncology
- Maintain current CVs and Medical Licenses for investigators
- Maintain current training documents 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 answering phones; faxing and filing of confidential documents; and basic Internet and email utilization
Requirements
- Bachelors degree in administration or science, OR
- At least three-years experience in Regulatory Affairs in a research setting
- Proficiency in Microsoft Word and Adobe Acrobat
- Excellent verbal and written communication skills
Benefits
- Excellent customer service to all internal and external customers
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory affairsdocument managementdata entryfeasibility assessmentclinical trial documentationadministrative dutiesMicrosoft WordAdobe AcrobatFileMakereDOCS
Soft Skills
communication skillsorganizational skillsinterpersonal skillsattention to detailtime management
Certifications
Bachelor's degree