Nebraska Cancer Specialists · 1 day ago
Research Regulatory Coordinator #HIRING
Omaha, NE
Full-time
Onsite
Entry Level
2+ years expNebraska Cancer Specialists (NCS) is committed to providing state of the art care to patients with oncologic and hematologic disorders. They are seeking a Research Regulatory Coordinator responsible for the preparation, submission, and maintenance of clinical trial regulatory documents and ensuring compliance with training requirements for research personnel.
BiotechnologyHealth CareMedicalOncology
Responsibilities
Prepares regulatory documentation packets and creates all Food and Drug Administration (FDA) 1572 forms
Ensures all necessary forms are submitted to sponsor company to activate protocols
Documents and tracks staff training and required courses for clinical trial department and providers
Reviews safety reporting with research personnel
Manages study closure documentation with the IRB and study sponsor
Distributes Informed Consent notifications regarding the need to reconsent patients and performs audits on signed informed consent documents
Update and maintain SharePoint including granting access to CRA’s for monitoring visits
Ensures providers and research staff have current documentation on file (CV/ML/GCP/additional as needed per study)
Create and update SOP’s as necessary
Qualification
Required
Associate degree in a clinical or scientific related discipline desired
Preferred
Bachelor's degree preferred
Minimum two years research experience preferred
Benefits
Affordable health, vision and dental insurance
Employer paid Long-term disability and life insurance
401K
Tuition Reimbursement
Employee Assistance Program
Generous paid time off plan including holidays and birthday
Company
Nebraska Cancer Specialists
Nebraska Cancer Specialists is a healthcare company that provides medical oncology, radiation oncology, and hematology services.
201-500 employees
Funding
Current Stage
Growth StageRecent News
2025-01-09
2024-03-21
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