Research Compliance Specialist II

Serves as regulatory liaison for all clinical sites, coordinating centers, and data management centers and performs grant approval reviews and assists with regulatory reviews. Coordinates investigator training sessions, assists with compliance investigations, maintains databases, and develops approval guidelines to ensure institutional compliance with all regulations, policies, and applicable regulations.  

%3Cp class=%22MsoNormal%22%3E%3Cspan style=%22font-size:10.0pt;%22%3E%3Cspan style=%22line-height:107%;mso-bidi-font-family:Calibri;mso-bidi-theme-font:minor-latin;%22%3EThe University of Pittsburgh Department of Neurological Surgery is hiring a Research Compliance Specialist II.%3C/span%3E%3C/span%3E%3C/p%3E%3Cp class=%22MsoNormal%22%3E%3Cspan style=%22font-size:10.0pt;%22%3E%3Cspan style=%22line-height:107%;mso-bidi-font-family:Calibri;mso-bidi-theme-font:minor-latin;%22%3EThis position will be responsible for regulatory duties for neurological surgery research studies and assist as needed with study coordination, not as primary coordinator. Manage regulatory responsibilities for research efforts in the Department of Neurosurgery, including coordinating with study team members to prepare and submit IRB applications (study start-up, modifications, continuing reviews, and required reporting). Maintain well-organized regulatory documentation to ensure compliance with institutional and federal guidelines.%3C/span%3E%3Cspan style=%22line-height:107%;mso-bidi-font-family:Calibri;mso-bidi-theme-font:minor-latin;mso-spacerun:yes;%22%3E%26nbsp; %3C/span%3E%3Cspan style=%22line-height:107%;mso-bidi-font-family:Calibri;mso-bidi-theme-font:minor-latin;%22%3EIND preparation and FDA reporting experience is preferred but not required. Collaborate with external sites to obtain regulatory approvals and support the management of regulatory files for multisite sIRB studies. Assist other study staff with duties related to overall study execution to ensure efficient and compliant project operations.%3C/span%3E%3Cspan style=%22line-height:107%;mso-bidi-font-family:Calibri;mso-bidi-theme-font:minor-latin;mso-spacerun:yes;%22%3E%26nbsp;%3C/span%3E%3Cspan style=%22line-height:107%;mso-bidi-font-family:Calibri;mso-bidi-theme-font:minor-latin;%22%3EServes as regulatory liaison for multiple clinical sites, coordinating centers, and data management centers for several research studies.%3C/span%3E%3Cspan style=%22line-height:107%;mso-bidi-font-family:Calibri;mso-bidi-theme-font:minor-latin;mso-spacerun:yes;%22%3E%26nbsp; %3C/span%3E%3Cspan style=%22line-height:107%;mso-bidi-font-family:Calibri;mso-bidi-theme-font:minor-latin;%22%3ECoordinates remote investigator training sessions, assists with compliance investigations, maintains databases, and develops approval guidelines to ensure institutional compliance with all regulations, policies, and applicable regulations.%3C/span%3E%3Cspan style=%22line-height:107%;mso-bidi-font-family:Calibri;mso-bidi-theme-font:minor-latin;mso-spacerun:yes;%22%3E %3C/span%3E%3Cspan style=%22line-height:107%;mso-bidi-font-family:Calibri;mso-bidi-theme-font:minor-latin;%22%3EThe University reserves the right to assign other duties to employees that are not listed in this job description.%26nbsp;%3C/span%3E%3C/span%3E%3C/p%3E%3Cp class=%22MsoNormal%22%3E%3Cspan style=%22mso-bidi-font-family:Calibri;mso-bidi-theme-font:minor-latin;%22%3EMinimum education to be considered for this position is a bachelor’s degree in a related field.%3C/span%3E%3C/p%3E%3Cp class=%22MsoNormal%22%3E%3Cspan style=%22color:black;font-size:10.0pt;%22%3E%3Cspan style=%22line-height:107%;mso-bidi-font-family:Calibri;mso-bidi-theme-font:minor-latin;mso-fareast-font-family:%26quot;Times New Roman%26quot;;mso-font-kerning:0pt;mso-ligatures:none;%22%3EInterested candidates, please go to %3C/span%3E%3C/span%3E%3Ca href=%22https://join.pitt.edu/%22%3E%3Cspan style=%22color:blue;font-size:10.0pt;%22%3E%3Cspan style=%22line-height:107%;mso-bidi-font-family:Calibri;mso-bidi-theme-font:minor-latin;mso-fareast-font-family:%26quot;Times New Roman%26quot;;mso-font-kerning:0pt;mso-ligatures:none;%22%3EHome | Talent Center: Careers at Pitt | University of Pittsburgh%3C/span%3E%3C/span%3E%3C/a%3E%3Cspan style=%22color:black;font-size:10.0pt;%22%3E%3Cspan style=%22line-height:107%;mso-bidi-font-family:Calibri;mso-bidi-theme-font:minor-latin;mso-fareast-font-family:%26quot;Times New Roman%26quot;;mso-font-kerning:0pt;mso-ligatures:none;%22%3E and use requisition #26006565 to apply for this position.%3C/span%3E%3C/span%3E%3C/p%3E
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Lab - Requires some bending, stooping, and stretching. Walking around laboratory benches and various common laboratory rooms within the Division. The candidate will use stairs often and may have to make multiple trips between common equipment rooms between floors. Requires normal range of hearing and eyesight to record, prepare, and communicate laboratory methods and results. Requires lifting up to 20lbs.

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The University of Pittsburgh is an equal opportunity employer / disability / veteran.

Job Details
Job Description: Med-Neurological Surgery, Pennsylvania-Pittsburgh
Assignment Category: Full-time regular
Job Classification: Staff.Research Compliance Specialist II
Job Family: Compliance & Audit
Job Sub-Family: Research Compliance
Campus: Pittsburgh
Minimum Education Level Required: Bachelor's Degree
Minimum Years of Experience Required: 2
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: M-F 8:30am-5pm Occasional Mornings, Evenings and Weekends as needed
Work Arrangement: On-Campus: Teams that work on campus, in an office, or in a lab.
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: Not Applicable