IRB Operations Manager
About the job
- A bachelor's degree is required.
- At least 5 years of experience in human subjects research oversight and day-to-day Institutional Review Board regulatory operations administration is required.
- Experience leading day-to-day Institutional Review Board regulatory operations, including supervising staff while ensuring regulatory compliance, is required.
- Strong knowledge of the Common Rule (45 CFR 46), applicable Food and Drug Administration human subjects research regulations, ethical principles governing research involving human participants, and exempt, expedited, and full board review processes is required.
- Experience managing Institutional Review Board submissions and regulatory workflows is required.
- Experience working with convened Institutional Review Board committees is required.
- The ability to interpret and apply complex research regulations and institutional policies is required.
- Strong organizational, analytical, and communication skills are required.
- Familiarity with Huron/eRIA or similar electronic research administration systems is required.
- Lead day-to-day operations of the Human Subjects Protection Program, supervise three full-time staff, and ensure 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 Institutional Review Board meetings.
- 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.
- 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 the company
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, New Jersey
Founded
2021
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Simplify's Take
What believers are saying
- August 2026 job postings show active hiring across New Brunswick, Newark, Rahway, and oncology.
- Vitalief’s trial-rescue and rapid-activation services fit persistent site turnover and study-startup delays.
- 2026 health-system positioning targets academic medical centers, acquired sites, and affiliated programs for expansion.
What critics are saying
- Vitalief disclosed only $2.75 million Series A on April 19, 2022; capital starvation limits scale.
- Services depend on sponsor and site outsourcing budgets; contract losses hit utilization immediately.
- AI-enabled rivals like Medidata and IQVIA can bundle software, squeezing Vitalief into commoditized labor.
What makes Vitalief unique
- Vitalief’s VELARA delivery platform centralizes consulting, resourcing, and managed services on August 22, 2026.
- Vitalief embeds teams across sponsors, CROs, and sites, with New Brunswick and King of Prussia offices.
- Vitalief Academy monetizes workforce upskilling, linking retention, performance, and clinical-trial execution since June 26, 2023.
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Benefits
- Health Insurance
- Life Insurance
- Disability Insurance
- 401(k) Retirement Plan
- Paid Holidays
- Paid Vacation
- Performance Bonus
- Company Equity