Clinical Trials Regulatory Affairs Specialist

CHEManager International; Pittsburgh (Allegheny County); Hybrid; USD 75,000 - 110,000; Full time

Job summary

CHEManager International seeks a Research Specialist - Regulatory/Compliance to join the Sponsored Clinical Trials & Partnerships Team in Pittsburgh. The role centers on pre-award activation of industry-sponsored trials by preparing and managing regulatory documentation for initial approvals and ongoing compliance.

You will collaborate with investigators, sponsors and institutional stakeholders to ensure regulatory integrity through the study lifecycle, and support post-award activities.

Qualifications

• 3 years of experience in industry clinical trials or research operations.
• 2 years of experience in regulatory or pre-award programs is strongly preferred.
• Knowledge of clinical research regulations (FDA, OHRP) or related exp is essential.
• Excellent analytical, organizational and communication skills.
• Ability to work independently and in a team; certification is a plus.

Responsibilities

• Prepare and review pre-award regulatory documents (ICF) in compliance with policies and regulations.
• Lead institutional review and negotiation of ICF language with industry sponsors for new protocol submissions and amendments.
• Guide study teams to submit approved ICFs to IRBs in accordance with regulations.
• Provide guidance on regulatory materials for Expanded Access and Compassionate Use studies while ensuring FDA compliance.
• Maintain submission records and tracking to support startup timelines and activation metrics.
• Provide regulatory guidance to investigators, sponsors, SCTP staff during startup.
• Post-award: ensure ongoing compliance with IRB approvals, amendments, and renewals per regulations.
• Support regulatory operations for SCTP and related systems.
• Identify process improvements in the pre-award workflow and contribute to quality initiatives.

Skills

Analytical skills

Organizational skills

Communication skills

Teamwork

Education

Bachelor's degree in health related field

Job description

CHEManager International seeks a Research Specialist - Regulatory/Compliance to join the Sponsored Clinical Trials & Partnerships Team in Pittsburgh. The role centers on pre-award activation of industry-sponsored trials by preparing and managing regulatory documentation for initial approvals and ongoing compliance.

You will collaborate with investigators, sponsors and institutional stakeholders to ensure regulatory integrity through the study lifecycle, and support post-award activities.