Compliance Specialist - Pittsburgh
23 hours ago
Job description
Drives activities and protocols in regard to compliance functions. Assists to mitigate organizational risks, evaluates compliance regulations, and prepares and presents compliance reports to management. Leads compliance and audit training sessions. Ensures adherence to all standards and regulations.Med-Neurology
The University of Pittsburgh, Department of Neurology Stroke Institute, is seeking a qualified Compliance Specialist to support the regulatory and centralized‑monitoring operations of the DUSK clinical trial, serving as part of the Clinical Coordinating Center (CCC).
This individual will work closely with the DUSK Project Manager and the Data Coordinating Center (DCC) to ensure that all participating study sites maintain full compliance with Good Clinical Practice (GCP), IRB requirements, federal regulations, and protocol‑specified obligations.
The Compliance Specialist will oversee regulatory documentation workflows, perform remote monitoring activities, support maintenance of the electronic Trial Master File (e‑TMF), and coordinate risk‑based centralized monitoring activities for external sites.
They will ensure that all required study documents are current, complete, and properly uploaded, and that site conduct adheres to the approved protocol.
Essential FunctionsServes as primary driver of existing controls and protocols designed to manage compliance activities.
Assists in tracking, analyzing, and mitigating organizational risks and issues related to compliance.
Evaluates current and new compliance regulations; Ensures adherence to internal standards and compliance with legal regulations.
Develops, monitors, and presents reports related to compliance management.
Maintains appropriate documentation of compliance reviews and determinations as required by federal regulations and by university policy.
Leads training sessions related to compliance and audit.
Physical Effort
Must be able to get around a university setting.
The University of Pittsburgh is an equal opportunity employer / disability / veteran.
Assignment Category
Full-time regular
Job Classification
Staff.
Compliance Specialist
Job Family
Compliance & Audit
Job Sub-Family
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.
Additional Details About Required Licensure/Certification
Minimum Qualifications:
Bachelor's degree (required) Master of Public Health (MPH) (required) Minimum 2 years of relevant experience in clinical research, compliance, regulatory affairs, or monitoring
Work Schedule
M-F, 8:30-5:00
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, Cover Letter
Optional Documents
Not Applicable
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