A Regulatory Affairs Specialist maintains specialized knowledge of state and federal government regulations that affect an employer. Interprets regulations and implements procedures that bring an employer into compliance with regulations; may audit internal compliance with regulations.
The Senior Research Specialist - Regulatory/Compliance is part of the Sponsored Clinical Trials and Partnerships Team and serves as an advanced regulatory practitioner and subject matter expert on informed consent, institutional compliance, and pre-award activation of industry-sponsored clinical trials. This role assists senior leadership in ensuring institutional regulatory compliance and oversight activities, provides mentorship to Research Specialists, and contributes to the development of SOPs, guidance documents, and process improvement initiatives within the SCTP team. Please note that this position is in-office three days per week. _Must be legally authorized to work in the United States, without requiring, now or in the future, sponsorship for employment visa status. UPMC does not offer any type of sponsorship_ _(H-1B, permanent residence, etc. )_ _UPMC does not participate in
STEM OPT.
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Responsibilities:
+ Performs and oversees complex portfolio of regulatory activities for high-complexity and multi-site industry-sponsored trials, including ICF preparation, negotiation, and submission. + Assists senior leadership with institutional regulatory compliance activities, oversight functions, and adherence to applicable FDA, OHRP, NIH, and HIPAA requirements across the portfolio. + Serves as subject matter expert on institutional ICF language, OHRP, FDA, and FCOI policies and guidelines. + Provides final sign-off on pre-award regulatory document packages, ensuring full congruency prior to IRB submission and study activation. + Leads development of tracking systems for new study submissions, including post-award amendments and modifications. + Leads preparation of complex site-specific regulatory submissions including INDs, IDEs, Expanded Access, and Compassionate Use studies (sINDs, HUDs, EAPs) in compliance with 21 CFR 312 and FDA guidance. + Drives development and maintenance of regulatory SOPs, guidance documents, and process improvement initiatives within the SCTP team. + Leads CTMS regulatory operations and drives optimization of pre-award tracking systems and activation metrics. + Assist senior leadership with responses to sponsor audits and FDA inspections; supports audit readiness across the regulatory portfolio. + Provides mentorship and professional guidance to Research Specialists, supporting their development in regulatory practice and institutional compliance. + Bachelor's Degree in health related field required. + 5 years of experience in industry clinical trials or research operations. + 4 years of experience in regulatory or clinical trial pre-award programs strongly preferred. + Equivalent combination of experience and education will be considered in lieu of above mentioned requirements. + Advanced knowledge of clinical research trials regulations, (i.e., Office of Research and Human Protections (OHRP) and Food and Drug Administration (FDA) is required or 3+ years' experience in drug development, regulatory or clinical operations functions. + Ability to work both independently part of a team and leading others. + Clincial Research Professional Certification or related is a plus. + Excellent analytical skills with attention to detail. + Excellent written and oral communication skills. + Excellent organizational and analytical skills with strong technical abilities. + No travel needed.
Licensure, Certifications, and Clearances:
+ Act 34 UPMC is an Equal Opportunity Employer/Disability/Veteran
