Vitalief

Clinical trial advisory and support services

IRB Operations Manager

Regulatory Compliance & EthicsConfirmed live in the last 24 hours

Full-timePrinceton, NJ, USA$130k - $170k

About the Job

Requirements

A bachelor's degree is required.
At least 5 years of experience in human subjects research oversight and day-to-day IRB regulatory operations administration is required.
Experience leading day-to-day IRB regulatory operations, including supervising staff while ensuring regulatory compliance, is required.
Strong knowledge of the Common Rule (45 CFR 46), applicable FDA human subjects research regulations, ethical principles governing research involving human participants, and exempt, expedited, and full board review processes is required.
Experience managing IRB submissions and regulatory workflows is required.
Experience working with convened IRB committees is required.
Ability to interpret and apply complex research regulations and institutional policies is required.
Familiarity with Huron/eRIA or similar electronic research administration systems is required.
Standing, sitting, walking, visual perception, talking, and hearing are required; the role may involve lifting up to 20 pounds.
On-site resources may be required by clients to receive annual influenza inoculation and pass a Mantoux Tuberculin Skin Test for Mycobacterium tuberculosis.

Responsibilities

Lead day-to-day operations of the Human Subjects Protection Program, supervising three full-time staff while ensuring regulatory compliance and efficient workflow.
Serve as a subject matter expert on human subjects research protections, ethics, and applicable federal regulations.
Oversee processing of research submissions, including new protocols, continuing reviews, amendments, and reportable events across exempt, expedited, and convened review pathways.
Provide regulatory guidance to investigators and research teams on human subjects protection requirements.
Coordinate pre- and post-meeting activities, ensure the quality of review materials, and approve meeting minutes for two monthly IRB meetings, one in person and one remote.
Identify operational efficiencies and partner with researchers, compliance teams, and administrative stakeholders to resolve regulatory issues and deliver training.
Manage protocol workflows, reporting, and recordkeeping through the Huron/eRIA research administration platform.

Desired Qualifications

An advanced degree is preferred.
Experience supporting academic research environments is preferred.
Experience supporting both social/behavioral research and biomedical/clinical research portfolios is a plus.

ABOUT VITALIEF
Vitalief is a trusted partner to Sponsors, CROs, and Sites across the research and clinical trials landscape. By blending deep subject matter expertise with strong business acumen, we deliver Consulting and Functional Service Provider (FSP) solutions that empower organizations to do more with less, streamlining operations, reducing costs, and accelerating breakthroughs that ultimately benefit patients.

POSITION SUMMARY
We are seeking an experienced IRB Operations Manager to join Vitalief as a full-time employee to initially provide leadership and operational support for one of Vitalief’s research clients’ Human Subjects Protection Program (HSPP). This resource will oversee the day-to-day operations of the HSPP, ensuring effective administration of institutional review processes, regulatory compliance, and protection of human research participants.

The ideal candidate will bring significant experience in IRB administration, human subjects research protections, federal research regulations, and program operations, with the ability to quickly assess processes, provide leadership continuity, and maintain high-quality service delivery.

WHY VITALIEF?

Impactful Work: Support leading research organizations in improving clinical research operations, strengthening compliance, and accelerating the delivery of innovative treatments to patients.
People-First Culture: Thrive in an environment that fosters growth, innovation, and collaboration.
Comprehensive Benefits: Enjoy 20 PTO days, 9 paid holidays, company-paid life insurance, short- and long-term disability, a 401(k)-retirement plan, and robust healthcare options.
Work Location: Hybrid role – 2 to 3 days onsite in Princeton, NJ, with remaining days remote.
Salary Range: $130,000 to $170,000 depending on experience and qualifications.

RESPONSIBILITIES

HSPP / IRB Program Oversight: Lead day-to-day operations of the HSPP, supervising three full-time staff while ensuring regulatory compliance and efficient workflow. Serve as subject matter expert on human subjects research protections, ethics, and applicable federal regulations.
IRB Review & Regulatory Compliance: Oversee processing of all research submissions (new protocols, continuing reviews, amendments, reportable events) across exempt, expedited, and convened review pathways. Provide regulatory guidance to investigators and research teams on human subjects protection requirements.
IRB Meeting Management: Coordinate pre- and post-meeting activities, ensure quality of review materials, and approve meeting minutes for two monthly IRB meetings (one in-person, one remote).
Process Improvement & Stakeholder Support: Identify operational efficiencies and partner with researchers, compliance teams, and administrative stakeholders to resolve regulatory issues and deliver training.
Systems & Documentation: Manage protocol workflows, reporting, and recordkeeping through the Huron/eRIA research administration platform.

QUALIFICATIONS

Bachelor’s degree required; advanced degree preferred.
5 or more years’ experience in human subjects research oversight and day-to-day IRB regulatory operations administration.
Experience leading day-to-day IRB regulatory operations, including supervising staff members while ensuring regulatory compliance.
Strong knowledge of Common Rule (45 CFR 46); FDA human subjects research regulations (as applicable); Ethical principles governing research involving human participants; Exempt, expedited, and full board review processes.
Experience managing IRB submissions and regulatory workflows.
Experience working with convened IRB committees.
Demonstrated ability to interpret and apply complex research regulations and institutional policies.
Strong organizational, analytical, and communication skills.
Experience supporting academic research environments is preferred.
Familiarity with Huron/eRIA or similar electronic research administration systems.
Experience supporting both social/behavioral research and biomedical/clinical research portfolios is a plus.

PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20 lbs.

IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis.

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About the Company

Vitalief

Clinical trial advisory and support services

Vitalief is a clinical trial solutions provider in New Brunswick, NJ that offers advisory and support services for pharmaceutical and healthcare clients. It helps plan and run clinical trials by recruiting top talent from the clinical research industry to ensure trials are completed successfully. Revenue comes from tailored advisory and support engagements rather than product sales. Vitalief differentiates itself with a people-first culture, investing in its team to deliver sustainable, high-quality services, and by adapting to industry changes such as increased telemedicine during COVID-19 to stay relevant and effective. The company’s goal is to support clients in delivering accurate, timely clinical trials that positively impact patient lives by providing skilled personnel and expert guidance.

Company size: 11-50
Company stage: Early VC
Total funding: $2M
Headquarters: New Brunswick, NJ
Founded: 2021

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