IRB ANALYST 2 OR 3
at LSU Health Sciences Center New Orleans
New Orleans, Louisiana, USA -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 08 Nov, 2024 | Not Specified | 09 Aug, 2024 | 2 year(s) or above | Medical Research,Regulatory Compliance,Training | No | No |
Required Visa Status:
Citizen | GC |
US Citizen | Student Visa |
H1B | CPT |
OPT | H4 Spouse of H1B |
GC Green Card |
Employment Type:
Full Time | Part Time |
Permanent | Independent - 1099 |
Contract – W2 | C2H Independent |
C2H W2 | Contract – Corp 2 Corp |
Contract to Hire – Corp 2 Corp |
Description:
POSITION SUMMARY
The LSU Health Sciences Center VCAA-Institutional Review Board has an opening for an Analyst 2/Analyst 3. The Institutional Review Board (IRB) is a federally mandated committee for institutions involved in research with human participants; it serves as a screening unit to review, evaluate, and make recommendations relative to research proposals that utilize human subjects. Institutional Review Board (IRB) is a federally mandated committee for institutions involved in research with human participants; it serves as a screening unit to review, evaluate, and make recommendations relative to research proposals that utilize human subjects
Analyst 2 – Under broad supervision and guidance from the Compliance Manager, the IRB analyst 2 is responsible for a range of activities for the Office of Research Services including, but not limited to: conducting pre-reviews of primarily no risk to minimal risk submissions to the IRB, including new protocols, continuing reviews, modifications, and unanticipated problems; attending IRB meetings and providing support to the IRB Chair and IRB Members, including if necessary, writing and editing minutes of meetings under the supervision of the Compliance Manager; assists in conducting quality control functions and post-approval monitoring; delivering relevant education programs; optimizing and streamlining departmental processes; and training IRB analysts and student helpers;. The incumbent also ensures compliance with federal regulations involving both Public Health Service and the Food & Drug Administration.
Analyst 3 – Reporting to the Compliance manager, the IRB Analyst 3 is responsible for a complex range of activities for the Office of Research Services including, but not limited to: conducting pre-reviews of minimal risk and greater than minimal risk submissions to the IRB, including Full Board and Device new protocols, continuing reviews, modifications, and unanticipated problems, Humanitarian Use Devices,
Expanded Access; organizing IRB meetings and providing support to the Compliance Manager, IRB Chair and IRB Members, including writing and editing minutes of meetings with minimal supervision; conducting quality control functions and post-approval monitoring; delivering relevant education programs; optimizing and streamlining departmental processes; and supervising and training IRB Analysts, research teams and student helpers;. The incumbent also ensures compliance with federal regulations involving both Public Health Service and the Food & Drug Administration.
REQUIRED EDUCATION
Bachelor’s
INDICATE THE TYPE OF EXPERIENCE REQUIRED TO DO THE JOB
Experience in scientific or medical research, admin support, healthcare, legal, regulatory compliance, or related areas WITH at least 2 years in direct IRB experience. Analyst 3 requires 4 years IRB exp.
INDICATE IF ANY COMBINATION OF SPECIFIC EXPERIENCE, TRAINING AND EDUCATION MAY BE SUBSTITUTED FOR THE REQUIRED EDUCATION OR EXPERIENCE
Master’s Degree may substitute for 2 year of general experience.
Preferred Qualifications
PREFERRED EDUCATION
Master’s
IF OTHER PREFERRED EDUCATION, PLEASE SPECIFY
Professional Research Certification through one of the professional research organizations.
INDICATE THE PREFERRED EXPERIENCE TO PERFORM THE JOB
Posting Detail Information
Responsibilities:
Please refer the Job description for details
REQUIREMENT SUMMARY
Min:2.0Max:4.0 year(s)
Financial Services
Pharma / Biotech / Healthcare / Medical / R&D
Finance
Graduate
Proficient
1
New Orleans, LA, USA