Senior Regulatory & Compliance Research Specialist

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

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.