Regulatory Specialist

Company Description

ALSA Research, founded in 1994, is a leading clinical research organization operating dedicated research facilities in New York City and Connecticut. As a second-generation family business, ALSA Research is committed to conducting high-quality clinical trials that support the development of safe and effective medications. The organization focuses on a wide range of indications and diseases, partnering with sponsors and investigators to advance medical knowledge. Team members contribute directly to research that improves patient care and expands treatment options.

Role Description

The Regulatory Specialist is responsible for coordinating and maintaining all regulatory documentation across ALSA's sites and ensuring compliance with applicable guidelines, institutional policies, and sponsor requirements. This fully remote role supports study start-up, submissions, and ongoing documentation throughout the lifecycle of each clinical trial. Working closely with our current Regulatory Manager, clinical teams, and sponsors, the Regulatory Specialist ensures that all regulatory materials are accurate, complete, and audit-ready in CRIO — our platform for CTMS, eSource, and eRegulatory.

This is an individual-contributor role with no direct reports, reporting to the Site Operations Manager. You'll receive structured onboarding and hands-on training from our current Regulatory Manager during their transition, so you'll ramp with support — but we're looking for someone mature and self-directed who won't need to be closely managed once up to speed.

Key Responsibilities

• Document Submission: Prepare and submit regulatory documents to IRBs, sponsors, and internal stakeholders, including initial submissions, amendments, continuing reviews, and safety reports.
• File Maintenance: Maintain and update Investigator Site Files (ISFs), regulatory binders, and electronic systems in CRIO to ensure documents are current and properly filed across all sites.
• Study Start-Up: Coordinate collection and submission of start-up documents such as site questionnaires, training logs, CVs, medical licenses, and delegation logs.
• Compliance Monitoring: Ensure documentation complies with ICH-GCP, FDA regulations (21 CFR Parts 11, 50, 54, 56, 312), and sponsor-specific requirements.
• Safety Reporting: Distribute IND safety reports to investigators and study teams and document their review.
• Stakeholder Liaison: Serve as the regulatory point of contact between research staff, investigators, sponsors, CROs, and IRBs to facilitate timely and accurate regulatory processes.
• Audit Readiness: Keep regulatory files continuously audit-ready and provide support during monitoring visits, sponsor audits, and inspections.
• Tracking & Reporting: Track expiration dates for approvals, licenses, and other time-sensitive documents; maintain regulatory logs and tracking tools.
• Meeting Support: Attend regulatory meetings, take minutes as needed, and provide updates on document status and submission timelines.

Note: This description outlines primary responsibilities; additional duties may be assigned as studies and operational needs evolve.

Required Qualifications

• Experience: 2+ years of clinical research experience — at a research site, CRO, or sponsor/pharma.
• Regulatory Knowledge: Working knowledge of ICH-GCP, FDA, and IRB regulatory requirements.
• Documentation Skills: Hands-on experience with regulatory document and/or eRegulatory workflows.
• Self-Direction: Highly organized, detail-obsessed, and genuinely self-directed — comfortable owning your work remotely across multiple sites.
• Communication: Strong written and verbal communication, with professionalism toward internal and external stakeholders.

Preferred Qualifications

• Site Background: Site-based regulatory experience (strongly preferred over sponsor/CRO-only backgrounds).
• CRIO Experience: Hands-on CRIO experience (strongly preferred — it's what we run on).
• Seniority Track: 5+ years in clinical research regulatory and/or CCRP, ACRP-CP, or RAC certification → considered for Senior Regulatory Specialist.
• Network Scale: Experience supporting a multi-site or site-network operation.