Research Specialist - Regulatory/Compliance

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 three days per week.

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.

• Bachelors degree in health related field.
• 3 years of experience in industry clinical trials or research operations.
• 2 year of experience in regulatory or clinical trial pre-award programs strongly preferred.
• Knowledge of clinical research trials regulations, (i.e., Office of Research and Human Protections (OHRP) and Food and Drug Administration (FDA) is essential. or 1+ years' experience in drug development, regulatory or clinical operations functions is strongly preferred.
• Excellent analytical skills with attention to detail.
• Strong organizational and time management skills.
• Excellent communication and interpersonal skills.
• Ability to work both independently and as part of a team.
• Clinical Research Professional Certification or related certification is a plus
  
  Licensure, Certifications, and Clearances:
  
• Act 34

UPMC is an Equal Opportunity Employer/Disability/Veteran