Regulatory Specialist

About ALSA Research

ALSA Research, established in 1994, is a premier clinical research organization with facilities located in New York City and Connecticut. As a family-owned business spanning two generations, ALSA Research dedicates itself to conducting rigorous clinical trials aimed at discovering safe and effective therapies across a broad spectrum of medical conditions. Collaborating with sponsors and investigators, the organization advances medical knowledge and directly contributes to enhancements in patient care and treatment alternatives.

Role Overview

The Regulatory Specialist will manage and coordinate all regulatory documentation across ALSA's clinical trial sites, ensuring full adherence to relevant guidelines, institutional standards, and sponsor mandates. Working completely remotely, this position supports the study start-up phase, submissions, and ongoing management of regulatory files throughout the clinical trial lifecycle. Key collaboration involves working alongside the existing Regulatory Manager, clinical teams, and sponsors to maintain accuracy, completeness, and audit readiness of regulatory records within CRIO—the platform used for CTMS, eSource, and eRegulatory.

This is an individual contributor position reporting to the Site Operations Manager. New hires will receive comprehensive onboarding and practical training from the current Regulatory Manager during transition. After this phase, the ideal candidate is expected to function independently with minimal supervision.

Primary Duties and Responsibilities

• Prepare and submit a variety of regulatory documents—including initial submissions, amendments, continuing reviews, and safety reports—to IRBs, sponsors, and internal parties.
• Maintain Investigator Site Files, regulatory binders, and electronic records within CRIO, ensuring all documents remain accurate, current, and correctly filed at all sites.
• Facilitate study start-up by gathering and submitting essential documents such as site questionnaires, training records, CVs, medical licenses, and delegation logs.
• Ensure compliance with applicable regulations and standards including ICH-GCP guidelines, FDA regulations (21 CFR Parts 11, 50, 54, 56, 312), as well as sponsor-specific requirements.
• Distribute IND safety reports to investigators and study teams and document their review accordingly.
• Act as the primary regulatory liaison connecting research personnel, investigators, sponsors, CROs, and IRBs to support efficient regulatory workflows.
• Maintain regulatory files in an audit-ready state at all times and provide assistance during monitoring visits, audits, and inspections.
• Monitor and track expiration dates for approvals, licenses, and other critical documents; maintain accurate regulatory logs and tracking systems.
• Participate in regulatory meetings, document minutes when required, and update relevant parties on the status of regulatory submissions and documentation timelines.

Required Qualifications

• Minimum of two years’ clinical research experience at a research site, CRO, sponsor, or pharmaceutical organization.
• Familiarity with ICH-GCP, FDA, and IRB regulatory standards and requirements.
• Experience handling regulatory document workflows and proficiency with eRegulatory processes.
• Strong organizational skills with meticulous attention to detail and an ability to work independently, managing tasks across multiple sites remotely.
• Excellent written and verbal communication skills and professionalism in interactions with internal and external stakeholders.

Preferred Qualifications

• Prior regulatory experience within a clinical research site strongly favored over sponsor- or CRO-only roles.
• Experience using CRIO software is highly desirable as it is ALSA’s current system.
• Five or more years of experience in clinical research regulatory roles and/or possession of certifications such as CCRP, ACRP-CP, or RAC may qualify for senior-level opportunities.
• Experience supporting operations across multiple sites or within a site network is advantageous.