IRB REGULATORY CONSULTANT
BRONX, NY, US
The IRB Regulatory Consultant will oversee regulatory operations of studies conducted by one or more Disease and Modality Team within Montefiore Einstein Cancer Center, including, internal (investigator-initiated studies), Cooperative group, and industrial protocols (pharmaceutical and biotechnology company studies).
The IRB Regulatory Consultant will work with investigators, study staff, local and Central Institutional Review Board, and the sponsor of the clinical trial to ensure that the studies are conducted in compliance with ICH GCP, the FDA, IRB, and other regulatory requirements.
Responsibilities:
The following regulatory duties will be performed under general supervision by the Assistant Director of Regulatory Affairs and/or Clinical Trials Manager-Regulatory Affairs:
1. Submit and obtain the approvals for clinical trials from internal committees and the Institutional Review Board (IRB).
2. Establish and maintain regulatory study files (electronic and Physical) to ensure that all essential regulatory documents are up to date, complete and in compliance with the requirement of ICH -GCP, IRB, the FDA, and other applicable regulations.
3. Participate in site feasibility visits and assist the study team in completing the feasibility questionnaires.
4. Collect, complete, and submit initial protocol, amendments, revisions to Informed Consent Forms (ICFs), continuing reviews, non-compliance issues, and study close out reports to the central and local IRB, as applicable.
5. Serve as a liaison between the IRB, Principal Investigator, and the sponsor to address regulatory queries & resolve any issues.
6. Prepare and revise the informed consent for studies where local IRB is the IRB of record.
7. Participate in the interim monitoring visits and resolve the open action items in a timely manner.
8. Ensure appropriate documentation of delegation log and training for all study staff members.
9. Actively suggests, implements, documents, and participates in departmental quality improvement activities.
10. Present regulatory status for disease group portfolio at applicable research meetings.
Requirements
Bachelor’s Degree; Master’s degree, preferred
1 year of related work experience
Experience in working with FDA regulations and guidelines, 21 CFR, ICH guideline and initiatives governing regulatory operations and submissions (pharma, biotech, medical devices).
Previous working or educational experience in the field of regulatory reporting and compliance
Department: CANCER CLINICAL TRIALS OFFICE Bargaining Unit: Non Union Campus: MOSES Employment Status: Regular Full-Time Address: 1575 Blondell Avenue, Bronx
Shift: Day Scheduled Hours: 9 AM-5:30 PM Req ID: 218077 Salary Range/Pay Rate: $62,400.00 - $80,000.00
For positions that have only a rate listed, the displayed rate is the hiring rate but could be subject to change based on shift differential, experience, education or other relevant factors.
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