Open to opportunities

Maria Feki

@mariafeki

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Senior IRB Analyst focused on rigorous research compliance, clear protocol support, and patient-safe study execution.

United States

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What I'm looking for

I’m looking to continue supporting research teams through high-quality IRB/clinical regulatory compliance—helping investigators prepare accurate submissions, strengthen policies and guidance, and ensure studies run smoothly from review to closure.

I’m a Senior IRB Analyst who reviews and processes IRB submissions—new studies, modifications, renewals, and check-ins—while editing protocols, consents, and recruitment materials to ensure regulatory compliance with federal and local requirements.

In my current role, I approve submissions or route them for final approval, support investigators with study preparation and submission questions, and review SMART IRB Reliance Agreements. I also guide researchers on early-stage device inventions by directing teams toward the appropriate FDA Device application and continuously improve policies and guidance for the research community.

Previously as a Senior Regulatory Specialist for Hematology Clinical Trials, I ushered studies from approval to closure, coordinated new hematology investigational drug submissions, handled IBC submissions for CAR-T and gene modification studies, and supported sponsor monitoring visits and site initiation activities. I’ve maintained regulatory files with GCP and other required documentation, ensured consistent DSMC reporting, tracked studies in Advarra eReg and Oncore (including transitioning platforms from CTMA), and supported training for new hires—often while managing an increased workload.

Experience

Work history, roles, and key accomplishments

Current

Senior IRB Analyst

Current

Carnegie Mellon University

Jan 2023 - Present (3 years 5 months)

Reviewed and processed IRB submissions (new studies, modifications, renewals, and check-ins), editing protocols and subject-facing documents to ensure regulatory compliance. Approved submissions or routed them for final approval, supported researchers with IRB policies and SMART IRB reliance review, and maintained research compliance guidance materials.

Regulatory Compliance Protocol & Consent Editing SMART IRB Reliance

Senior Regulatory Specialist

UPMC Hillman Cancer Center

Mar 2019 - Dec 2022 (3 years 9 months)

Managed hematology clinical trial regulatory activities from approval through closure, including IRB submissions to local and central boards and IBC submissions for CAR-T and gene modification studies. Prepared for sponsor monitoring visits and site visits, maintained regulatory files and DSMB reporting, and doubled workload after a coworker left the position.

Clinical Trials Regulatory Affairs IRB Submission GCP Compliance IBC Submissions (CAR T Gene Therapy)DSMB Reporting Sponsor Monitor Advarra EReg OnCore

IACUC Regulatory Coordinator

University of Pittsburgh

May 2011 - Mar 2019 (7 years 10 months)

Provided regulatory and administrative support for the Institutional Animal Care and Use program, including review of protocols, modifications, and renewals. Coordinated outside institute collaborations and prepared regulatory correspondence to OLAW, AAALAC, and the USDA, while troubleshooting the online protocol system for investigators and staff.

IACUC Compliance Animal Care & Use Protocol Review AAALAC Liaison USDA Regulatory Support

Legal Contracts Coordinator

O’Brien, Rulis & Bochicchio, LLC

Nov 2009 - May 2011 (1 year 6 months)

Composed contracts to support case settlements and prepared invoices for transcripts, medical bills, and medical records. Coordinated claim-related correspondence with adjusters to provide updates on developments.

Contract Drafting Invoice Processing Medical Records Coordination Administrative Legal Support

Workers Comp & SSD Coordinator

Rudberg Law Offices, LLC

Sep 2008 - Oct 2009 (1 year 1 month)

Coordinated Workers’ Compensation and Social Security Disability department activities and managed related administrative workflows. Developed new policies and procedures to organize and improve Social Security Disability operations.

Social Security Disability Policy Development