Research Specialist - Regulatory/Compliance

UPMC; Pittsburgh (Allegheny County); On-site; USD 65,000 - 90,000; Full time

Job summary

UPMC is seeking a Research Specialist – Regulatory/Compliance to support pre-award regulatory activities for industry-sponsored trials. The role focuses on preparing regulatory documentation, reviewing ICF language, and ensuring regulatory integrity from pre-award through study closure.

You will collaborate with investigators, sponsors, and SCTP stakeholders to meet FDA, OHRP, NIH, and HIPAA requirements and to maintain compliance throughout the lifecycle of assigned studies.

Qualifications

• Experience with regulatory documentation for clinical trials (ICF, regulatory submissions)
• Familiarity with FDA regulations (21 CFR Parts 50, 54, 56, 312, 812) and ICH-GCP E6
• Ability to coordinate with IRBs, sponsors, investigators and study teams

Responsibilities

• Prepare and review pre-award regulatory documents in compliance with policies and sponsor requirements.
• Lead institutional review and negotiation of ICF language with industry sponsors for protocol submissions and amendments.
• Guide study teams to submit approved ICFs to IRBs in accordance with applicable CFRs and procedures.
• Provide regulatory guidance for Expanded Access and Compassionate Use studies while supporting timely activation.
• Maintain submission records and tracking systems to support decision-making and startup timelines.
• Provide regulatory SME support to investigators, SCTP consultants, contractors, and study teams during startup.
• Post-award: ensure ongoing compliance with IRB approvals, amendments, and renewals; support regulatory operations for UPMC CTMS; identify process improvements; ensure HIPAA and FDA/OHRP/NIH requirements are met; assist in SOP development and maintenance

Job description

Purpose

The Research Specialist – Regulatory/Compliance focuses is part of the Sponsored Clinical Trials and Partnerships Team. The role focuses on pre-award activation of industry-sponsored clinical trials by preparing and managing regulatory documentation required for initial approvals and ongoing compliance and integrity. This role ensures the regulatory integrity of assigned studies from pre-award through study closure, working closely with investigators, sponsors, and institutional stakeholders to meet all applicable requirements.

Please note that this position is in-office 3 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

• Prepare and review pre-award regulatory documents, namely informed consent forms (ICF), in compliance with UPMC policies/language, sponsor requirements, and 21 CFR Parts 50, 54, 56, 312, 812, 45 CFR 46, and ICH-GCP E6.
• Conduct and lead institutional review and negotiation of ICF language with industry sponsors for new protocol study submission and study amendments.
• Guide study teams to properly submit approved ICFs to Institutional Review Boards (IRBs) in accordance with 21 CFR Part 56 and institutional procedures.
• Provide guidance to study teams by reviewing and approving regulatory materials for Expanded Access and Compassionate Use studies (sINDs, HUDs, EAPs, etc.), ensuring compliance with 21 CFR 312 and FDA guidance, while supporting timely activation.
• Maintain accurate submission records and tracking systems to support pre-award decision-making, study startup timelines, and study activation metrics.
• Provide regulatory guidance and act as a subject matter expert for investigators, sponsors, SCTP consultants, SCTP contractors, and study teams during the startup phase of clinical trials.
• Post-award:
  • Assist study teams in ensuring ongoing compliance by confirming industry-sponsored trials are conducted under the most current IRB approvals, amendments, and renewals, per 45 CFR 46
  • Support regulatory operations for UPMC CTMS.
  • Identify process improvement opportunities in the pre-award regulatory workflow and contribute to quality initiatives within the Sponsored Clinical Trials & Partnerships (SCTP) team.
  • Support organizational compliance by ensuring all applicable FDA, OHRP, NIH, and HIPAA requirements are met prior to study initiation and throughout the lifecycle of assigned studies.
  • Assists SCTP management with development and maintenance of SOPs and guidance documents.