What are the responsibilities and job description for the Research Regulatory Coordinator position at Nebraska Cancer Specialists?
Description
Nebraska Cancer Specialists (NCS) is committed to providing state of the art care to our patients with oncologic and hematologic disorders in a compassionate and caring manner, and to advance cancer treatment through research and education. We continuously strive to be known as the most knowledgeable, progressive, trusted and compassionate cancer practice in the region.
We are seeking a Research Regulatory Coordinator who will be responsible for the preparation, submission, and maintenance of clinical trial regulatory documents and maintaining training documents for appropriate research personnel.
- 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.
GREAT NCS BENEFITS:
- Monday through Friday, daytime hours, no holidays, evenings or weekends.
- Affordable health, vision and dental insurance,
- Employer paid Long-term disability and life insurance
- 401K, Tuition Reimbursement and an Employee Assistance Program
- Generous paid time off plan including holidays and birthday.
Requirements
- Associate degree in a clinical or scientific related discipline desired, Bachelor’s degree preferred.
- Minimum two years research experience preferred.
Our team embodies our core values: PURPOSE, INNOVATION, RELATIONSHIP & EXCELLENCE. NCS is an equal opportunity employer and participates in E-Verify.