IQVIA · 5 hours ago
Regulatory Affairs Coordinator
Dallas, TX
Full-time
Onsite
Entry Level
$46K/yr - $96K/yr
3+ years expIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. The Regulatory Affairs Coordinator will act as a liaison between NEXT Oncology and various Pharmaceutical and Biotech companies to open clinical trials, ensuring compliance with the Institutional Review Board and maintaining regulatory documentation.
AnalyticsHealth CareLife Science
Responsibilities
Submit new studies to the Institutional Review Board (IRB) for approval
Submit changes to the protocol, informed consent forms, investigator’s brochures, serious adverse event reports, safety reports (i.e., SUSARs or similar reports), and protocol deviations to the IRB
Ensure studies are kept open at the IRB by submitting continuing review reports on time
Submit closure notifications to the IRB as necessary when applicable
Give tours of NEXT Oncology to clinical trial Sponsors and other visitors as applicable
Complete feasibility questionnaires for proposed clinical trials
Set up Protocol Review and Feasibility Committee 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
Set up 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
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 certifications and ranges for all laboratories being used in the conduct of clinical trials 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
Work with Research Coordinators to ensure training documentation provided to the Regulatory Department is accurate
Receive incoming correspondence/files and review/forward to appropriate staff
Attend Phase I meetings, Site Qualification Visit 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
Qualification
Required
Bachelor's degree in administration or science
Preferred
Three years' experience in a medical or research setting preferred but not required
Benefits
Incentive plans
Bonuses
Health and welfare and/or other benefits
Company
IQVIA
IQVIA provides analytics, compliance, and management solutions to the life sciences industry.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$3.5B2025-06-02Post Ipo Debt· $2B
2023-11-14Post Ipo Debt· $500M
2023-05-18Post Ipo Debt· $1B
Leadership Team
Chris Colapietro
Vice President, Customer Engagement
Jonathan Morris
VP & GM US Healthcare
Recent News
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