Research Specialist - Regulatory/Compliance

UPMC•Pittsburgh, PA

3d•Hybrid

About The Position

The Research Specialist – Regulatory/Compliance is part of the Sponsored Clinical Trials and Partnerships Team. The position focuses on pre-award activation of industry-sponsored clinical trials by preparing and managing regulatory documentation for initial approvals and ongoing compliance. It ensures the regulatory integrity of assigned studies from pre-award through study closure, working with investigators, sponsors, and institutional stakeholders to meet applicable requirements. The position is in-office three days per week. The specialist prepares and reviews pre-award regulatory documents, particularly informed consent forms, and guides teams through submissions and regulatory requirements. The role also supports post-award compliance, UPMC CTMS regulatory operations, process improvement, and the development and maintenance of standard operating procedures and guidance documents. Applicants must be legally authorized to work in the United States without requiring current or future employment visa sponsorship. UPMC does not offer visa sponsorship and does not participate in STEM OPT.

Requirements

Bachelor’s degree in a health-related field.
Three years of experience in industry clinical trials or research operations.
Knowledge of clinical research trial regulations, including Office for Human Research Protections (OHRP) and Food and Drug Administration (FDA) requirements.
Excellent analytical skills and attention to detail.
Strong organizational and time management skills.
Excellent communication and interpersonal skills.
Ability to work independently and as part of a team.
Legal authorization to work in the United States without current or future employment visa sponsorship.

Nice To Haves

Two years of experience in regulatory or clinical trial pre-award programs.
One or more years of experience in drug development, regulatory, or clinical operations functions.
Clinical Research Professional Certification or a related certification.

Responsibilities

Prepare and review pre-award regulatory documents, including informed consent forms, in accordance with UPMC policies and language, sponsor requirements, and applicable regulations and guidance.
Lead institutional review and negotiation of informed consent form language with industry sponsors for new protocol submissions and study amendments.
Guide study teams in submitting approved informed consent forms to Institutional Review Boards (IRBs) in accordance with regulations and institutional procedures.
Review and approve regulatory materials for Expanded Access and Compassionate Use studies, including sINDs, HUDs, and EAPs, and guide study teams to support compliance and timely activation.
Maintain accurate submission records and tracking systems for pre-award decision-making, study startup timelines, and study activation metrics.
Provide regulatory guidance and subject matter expertise to investigators, sponsors, SCTP consultants and contractors, and study teams during clinical trial startup.
Support ongoing compliance by confirming industry-sponsored trials are conducted under current IRB approvals, amendments, and renewals.
Support regulatory operations for UPMC CTMS.
Identify pre-award regulatory workflow improvements and contribute to quality initiatives within the SCTP team.
Ensure applicable FDA, OHRP, NIH, and HIPAA requirements are met before study initiation and throughout assigned studies.
Assist SCTP management with developing and maintaining SOPs and guidance documents.