IRB Operations Manager

Vitalief • Princeton, NJ • 1h ago

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.

Competitive Compensation: Salary based 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.

Similar Jobs

Transcend PMO Senior Operations Manager

J&J Family of Companies • Titusville, NJ • 1h ago

Management & Administrative

At Johnson & Johnson,?we believe health is everything. Our strength in healthcare innovation empowers us to build a?world where complex diseases are prevented, treated, and cured,?where treatments are smarter and les...

1h ago

Go to Apply

Sales Operations Manager- Commercial, Ford Energy

Ford Motor Company • Trenton, NJ • 1h ago

Management & Administrative

The Sales Operations Manager - Commercial Contract is a high-impact functional role responsible for defining, executing, and safeguarding the commercial contract pipeline and sales operations frameworks within the Ford E...

1h ago

Go to Apply

Solutions Manager

Six Flags • Jackson, NJ • 5h ago

Management & Administrative

Overview: This position reports to the Director of Sales and Marketing and oversees a team of seasonal or part-time associates to process group and partnership agreements or group tickets and event orders to increase rev...

5h ago

Go to Apply

Performance Marketing Manager

Cardinal Health • Trenton, NJ • 6h ago

Management & Administrative

What Digital Performance Marketing contributes to Cardinal Health Marketing is responsible for assessing customer needs, market conditions and competition to inform business strategy. Marketing implements the strategy th...

6h ago

Go to Apply

Program Manager

Actalent • Edison, NJ • 6h ago

Management & Administrative

Responsibilities: Coordinating proposals for new opportunities Engaging new customers that support the organization's objectives Working with team members to develop budgets and plans for the projects & preparing nec...

6h ago

Go to Apply

Customer Service Representative

DuBois Chemicals Inc • Bristol, PA • 21h ago

Management & Administrative

It's fun to work in a company where people truly BELIEVE in what they are doing! We're committed to bringing passion and customer focus to the business. POSITION SUMMARY: DuBois Chemicals is seeking a full-time Customer...

21h ago

Go to Apply

Customer Service Advisor

Valvoline • Levittown, PA • 21h ago

Management & Administrative

Valvoline Instant Oil Change (VIOC) is looking for a career-driven individual to fil l a Customer Service Advisor (CSA) position As a Customer Service Advisor, you are often the first and last face our guests see. You wi...

21h ago

Go to Apply

customer service

Dollar Tree • South Plainfield, NJ • 21h ago

Management & Administrative

Your positive, friendly disposition and eagerness to get things done make you the right person for our Customer Service Associate II position. Join our team today and let's create an inviting shopping experience for our...

21h ago

Go to Apply

Operations Manager

Amazon • Burlington, NJ • 1d ago

Management & Administrative

Description Job summary Our WW Operations network delivers millions of packages and smiles to Amazon customers every day. We are looking for motivated, customer-focused individuals who want to join our team as an Operati...

1d ago

Go to Apply

Operations Manager

CVS Health • Kendall Park, NJ • 1d ago

Management & Administrative

We're building a world of health around every individual - shaping a more connected, convenient and compassionate health experience. At CVS Health®, you'll be surrounded by passionate colleagues who care deeply, innovate...

1d ago

Go to Apply

Subscribe to get new jobs sent directly to you
(no charge, cancel anytime)