Clinical Trials Regulatory Specialist - Pre-Award Activation

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

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.