Regulatory Affairs Assistant
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. At NEXT Oncology (an Avacare Business), you’ll be part of a mission-driven team that values collaboration, precision, and patient safety. Our team is known for its supportive culture, strong communication, and commitment to excellence in clinical research. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
