IRB Operations Manager

Vitalief; Princeton (NJ); Hybrid; USD 80.000 - 100.000; Vollzeit

Benefits dieser Stelle

20 PTO days

9 paid holidays

Company-paid life insurance

401(k) retirement plan

Robust healthcare options

Zusammenfassung

Vitalief is seeking an experienced IRB Operations Manager to oversee day-to-day operations of the Human Subjects Protection Program (HSPP) in Princeton, NJ. The ideal candidate will bring over 5 years of experience in human subjects research and IRB administration, ensuring compliance and effective administration.

This hybrid role includes both onsite and remote work, with robust benefits including PTO, healthcare options, and competitive compensation based on experience.

Qualifikationen

• 5+ years of experience in human subjects research oversight and IRB operations.
• Experience leading and supervising IRB regulatory operations.
• Strong understanding of Common Rule and FDA regulations.

Aufgaben

• Oversee day-to-day operations of the HSPP.
• Coordinate and manage IRB review processes and compliance.
• Identify operational efficiencies and support stakeholders.

Kenntnisse

Human subjects research oversight

Regulatory compliance

Leadership

Strong communication skills

Organizational skills

Ausbildung

Bachelor’s degree

Advanced degree (preferred)

Tools

Huron/eRIA or similar systems

Jobbeschreibung

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.