Sr Research Specialist - Regulatory/Compliance

UPMC; Pittsburgh (Allegheny County); On-site; USD 90,000 - 115,000; Full time

Job summary

UPMC is seeking a Senior Research Specialist – Regulatory/Compliance to lead advanced regulatory activities for industry-sponsored trials within the SCTP team in Pittsburgh. You will mentor staff, ensure regulatory oversight, and help implement SOPs and improvement initiatives.

The role requires expertise in ICF language, FDA guidance, HIPAA requirements, and IRB submissions, with in-office work three days per week.

Qualifications

• Experience overseeing regulatory activities for industry-sponsored trials.
• Familiarity with FDA, OHRP, NIH, and HIPAA requirements.
• IRB submission and clinical trial documentation experience.

Responsibilities

• Oversees complex regulatory activities for multi-site industry-sponsored trials, including ICF preparation and submission.
• Assists senior leadership with institutional regulatory compliance and oversight functions.
• Serves as SME on ICF language, policies, and FDA guidance.
• Provides final sign-off on pre-award regulatory packages prior to IRB submission.
• Leads development of tracking systems for study submissions and amendments.
• Drives SOPs and process improvements within SCTP.
• Supports sponsor audits and inspections, aiding readiness.

Skills

Regulatory compliance

Pre-award activation

IRB/clinical trial submissions

Education

Bachelor's degree in life sciences or related field

Tools

CTMS

FDA/IRB guidelines

Job description

Purpose:
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.
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.