Description
IRB Specialist II
Med-Ophthalmology - Pennsylvania-Pittsburgh - (26000723)
The University of Pittsburgh, Ophthalmology Department Clinical Trials is searching for an IRB Specialist. The IRB Specialist II will serve as a regulatory expert responsible for managing the protocol review process by ensuring compliance with federal regulations, state law, and University of Pittsburgh policies and procedures. Provides regulatory and ethical training and guidance for IRB members and the research community at large through consultation and education.
Qualification of candidate :
o B.A degree or 5 years of experience preferably in an Ophthalmology health care setting OR 3 years of experience working in Clinical Trials
o Familiarity with EPIC, Pitt Pro, OSPARS Portal, MyRa, PERIS, and IBC is preferred.
o Excellent knowledge of software packages including Microsoft Word, Excel, Access, PowerPoint and Outlook is preferred.
Job Summary
Serves as a regulatory expert responsible for managing the protocol review process by ensuring compliance with federal regulations, state law, and University of Pittsburgh policies and procedures. Provides regulatory and ethical training and guidance for IRB members and the research community at large through consultation and education
Essential Functions
Some of the additional responsibilities will be:
• Ensuring patient visits are processed and charged appropriately in Epic
• Build relationships with Clinical Trials Manager, department administrators, Industry sponsors, financial administrators, and other users.
• Serve as a liaison between the Clinical Trials Staff and Industry Sponsored representatives as required.
• Invoicing for participant visits as indicated by Industry Sponsored protocols in a timely manner.
• Respond to business/reporting requests by departmental leadership.
• Tracking payment received from collaborating departments.
Physical Effort
Ability to work with a computer and have keen focus.
Assignment Category: Full-time regular
Job Classification: Staff.IRB Specialist II
Job Family: Compliance & Audit
Job Sub Family: Institutional Review Board
Campus: Pittsburgh
Minimum Education Level Required: Bachelor's Degree
Minimum Years of Experience Required: 3
Will this position accept substitution in lieu of education or experience: Combination of education and relevant experience will be considered in lieu of education and/ or experience requirement.
Work Schedule: between M- F 8:30am to 5:00pm
Work Arrangement: Hybrid: Combination of On-Campus and Remote work as determined by the department.
Hiring Range: TBD Based Upon Qualifications
Relocation_Offered: No
Visa Sponsorship Provided: No
Background Check: For position finalists, employment with the University will require successful completion of a background check
Child Protection Clearances: Not Applicable
Required Documents: Resume
Optional Documents: Cover Letter
PI282239767