Study Start-up and Regulatory Manager

Location: Research Triangle Park, North Carolina, United States; hybrid schedule with 3 days in office and 2 days remote

Company

hirify.global combines health system partnerships, longitudinal data curation, and modern study design to generate multimodal evidence for pharmaceutical, biotech, provider, and payer organizations.

What you will do

• Independently prepare and manage initial IRB/IEC submissions, continuing reviews, and amendments across multiple clinical research studies.
• Lead study start-up and regulatory activities for Phase I–IV investigational drug and biologic, observational, and medical device studies.
• Establish and maintain audit-ready Trial Master Files in accordance with ICH-GCP, sponsor requirements, and applicable regulations.
• Collect, review, track, and renew essential regulatory documents, including Form FDA 1572s, CVs, licenses, financial disclosures, approvals, insurance certificates, and laboratory certifications.
• Coordinate study-document translations and liaise with sponsors, CROs, investigative sites, and IRBs/ECs to support timely approvals and issue resolution.
• Maintain regulatory tracking systems, provide status updates, and support site contract and budget negotiations as needed.

Requirements

• Bachelor's degree.
• At least 3 years of experience independently performing IRB submissions, essential document collection, and TMF maintenance or comparable activities.
• Experience supporting Phase I–IV investigational and observational submissions.
• Working knowledge of ICH-GCP guidelines, FDA regulations, and IRB/IEC submission requirements.
• Strong organization, communication, and prioritization skills with the ability to manage multiple concurrent projects independently.
• Ability to work in a hybrid environment based in Research Triangle Park, North Carolina, with 3 days in the office and 2 days remote.

Nice to have

• Experience supporting medical device submissions.
• Experience with site contract and budget negotiations.

Culture & Benefits

• Hybrid work arrangement with regular onsite collaboration.
• Health, dental, and vision coverage.
• 401(k) plan with company match.
• Generous paid time off and paid parental leave.