Pre-Award Clinical Regulatory Specialist - In-Office 3 Days

Pittsburgh Tomorrow; Pittsburgh (Allegheny County); Hybrid; USD 70,000 - 90,000; Full time

Job summary

UPMC is seeking a Research Specialist – Regulatory/Compliance to focus on pre-award activation of industry-sponsored clinical trials by preparing regulatory documentation and ensuring ongoing compliance. The role works closely with investigators, sponsors, and institutional stakeholders to meet all requirements and maintains regulatory integrity from pre-award through study closure.

The position is in-office 3 days per week.

Qualifications

• Bachelor's degree in health related field.
• 3 years of experience in industry clinical trials or research operations.
• 2 years of experience in regulatory or pre-award programs preferred.
• Knowledge of FDA/OHRP and HIPAA requirements.
• Excellent analytical skills with attention to detail.
• Strong organizational and time management skills.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team.

Responsibilities

• Prepare and review pre-award regulatory documents (ICFs) in compliance with policies and regulatory requirements.
• Lead ICF language discussions with sponsors for new protocol submissions and amendments.
• Guide teams to submit approved ICFs to IRBs per procedures.
• Review regulatory materials for Expanded Access and Compassionate Use studies ensuring compliance.
• Maintain submission records and tracking systems for startup timelines and activation metrics.
• Provide regulatory guidance to investigators, sponsors, SCTP consultants, contractors, and study teams during startup phase.
• Post-award: ensure ongoing compliance with IRB approvals, amendments, and renewals.

Skills

Regulatory knowledge

IRB submissions

Documentation

Communication

Time management

Education

Bachelor's degree in health related field

Job description

UPMC is seeking a Research Specialist – Regulatory/Compliance to focus on pre-award activation of industry-sponsored clinical trials by preparing regulatory documentation and ensuring ongoing compliance. The role works closely with investigators, sponsors, and institutional stakeholders to meet all requirements and maintains regulatory integrity from pre-award through study closure.

The position is in-office 3 days per week.