REGULATORY COORDINATOR

Under supervision, the Regulatory Coordinator will work with the Cancer Center Clinical Trials Office (CC-CTO) and be responsible for managing all regulatory activities and processing and submitting all documentation related to the Institutional Review Board (IRB), Research Review Committee (RRC), Clinical Trials Research Center (CTRC), and pharmaceutical company regulatory mandates as required for NCI, industry-sponsored, and investigator-initiated protocols. The Regulatory Coordinator must also maintain credentialing for all Cancer Center, partner, and contracted affiliate site Investigators and Research Associates through the NCI and related cooperative groups.

Duties include monitoring Cooperative Group/Pharmaceutical broadcasts for updates, maintaining electronic and paper files for dissemination, writing consents, facilitating and processing new protocols, completing and submitting adverse event forms, preparing regulatory records for all site audits, and other duties as assigned.

Job Duties

• Monitor Cooperative Group/Pharmaceutical broadcasts for updates.
• Download and process investigator notifications and consent forms for IRB submission in accordance with the local IRB and federal (FDA) mandates.
• Maintain electronic and paper records of regulatory files for dissemination to affiliate site personnel.
• Write consents in accordance with the local IRB and federal (FDA) mandates; complete IRB application and re-approval forms including documentation required for submission of new studies to the RRC.
• Facilitate new protocols through the submission process to relevant University committees.
• Post approvals to databases as they are obtained.
• Refer to the study enrollment database for progress of subjects accrued to clinical trials.
• Complete & submit adverse event forms to the IRB and pharmaceutical companies.
• Create documentation required for new study submissions to the CTRC which includes study aims, designs, & methods, progress reports, data analysis, and budgets.
• Maintain and update regulatory binders per cooperative group audit and pharmaceutical monitoring requirements.
• Track IRB submissions and approvals.
• Manage all hardcopy and electronic records to assure correlation with the most current approved protocol and consent forms.

Job Requirements

Bachelor's degree and three years of related professional work experience. Master’s degree can substitute for two years of work experience.

LSU Health New Orleans seeks candidates who will contribute to a climate where students, faculty, and staff of all identities and backgrounds have equitable access and success opportunities. As an equal opportunity employer, we welcome all to apply without regard to race, color, religion, age, sex, national origin, physical or mental disability, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. LSU Health New Orleans is also designated as a State As a Model Employer (SAME) agency and provides assistance to persons needing accommodations or with the accessibility of materials. For those seeking such accommodations or assistance related to this search, we encourage you to contact the Office of Human Resource Management (HRMADA@lsuhsc.edu).

Comprehensive benefits are available to eligible employees and their dependents including health, life, dental, and vision insurance; flexible spending accounts; retirement plans; generous annual and sick leave; 14 paid holidays per year; and an employee health primary care clinic. See following link for more details on our benefits offerings: LSUHSC, New Orleans - Benefits

Other employee benefits include a full-service credit union, wellness benefits featuring complimentary fitness center membership for employees and their spouses, employee assistance program, campus assistance program, and pet insurance option. More information about these benefits can be found on this webpage: Additional Benefits

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Retirement plan
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Work Location: In person