Regulatory Research Coordinator II – IRB & Sponsor Liaison

Dartmouth-Hitchcock Health; Lebanon (NH); On-site; USD 70,000 - 90,000; Full time

Job summary

Dartmouth-Hitchcock Health in Lebanon, NH seeks a Research Regulatory Coordinator II to independently manage tasks related to IRBs and study sponsors. You will work with study teams, regulatory committees, and research administration to ensure compliance with regulatory guidelines.

The role requires navigating FDA, OHRP, ICH, and JC frameworks, maintaining essential documents, and supporting investigators with protocol submissions and approvals.

Qualifications

• Bachelor's degree or equivalent experience required.
• Minimum 2 years of relevant research experience.
• Ability to travel as required.
• SOCRA/ACRP Certification or eligibility preferred.

Responsibilities

• Record management and IRB submissions in compliance with SOPs.
• Develop reports on protocol activity, safety, and compliance.
• Support resolution of sponsor and regulatory issues and advise IRB/study team.
• Communicate with sponsors regarding study status.
• Assist investigators with submissions and approvals for trials.
• Maintain knowledge of FDA, OHRP, ICH, JC and related guidelines.

Skills

Research experience

Education

Bachelor's degree or equivalent

2 years of relevant research experience

Job description

Dartmouth-Hitchcock Health in Lebanon, NH seeks a Research Regulatory Coordinator II to independently manage tasks related to IRBs and study sponsors. You will work with study teams, regulatory committees, and research administration to ensure compliance with regulatory guidelines.

The role requires navigating FDA, OHRP, ICH, and JC frameworks, maintaining essential documents, and supporting investigators with protocol submissions and approvals.