Regulatory Specialist - Clinical Research

Position Overview

• The Regulatory Specialist II supports the planning, preparation, and maintenance of essential regulatorydocumentation required for clinical research studies
• This role ensures compliance with federal, state, and local regulations, as well as internal policies and procedures
• The Regulatory Specialist II collaborates closely with Operations, Quality, and Compliance teams to ensure all regulatory activities are completed accurately and on schedule

Key Responsibilities

• Prepare, submit, and maintain IRB submissions, including initial, continuing review, amendment, promptly reportable event, and closure documents
• Maintain electronic Investigator Site Files (eISF), ensuring essential regulatory documents are current, complete, and compliant
• Collaborate with Principal Investigators (PIs) and Clinical Research Coordinators (CRCs) to obtain required signatures, approvals, and certifications
• Track and update investigator and staff credentials, medical licenses, CVs, and training certificates (CITI, GCP, etc), ensuring timely renewals
• Prepare study start-up documentation, including Form 1572, financial disclosure forms, delegation logs, and regulatory binders
• Maintain and regularly update regulatory tracking logs and study status reports for active and pending protocols
• Communicate directly with sponsors, CROs, and internal stakeholders to address regulatory queries and documentation requests
• Review and document protocol deviations, ensuring proper reporting and follow-up under the supervision of the Senior Regulatory Specialist or VP of Compliance
• Support the documentation and reporting of Adverse Events (AEs) and Serious Adverse Events(SAEs) in accordance with GCP and protocol requirements
• Participate in internal audits, monitoring visits, and sponsor inspections, ensuring regulatory readiness and documentation accuracy
• Contribute to the development and standardization of regulatory templates, forms, and process workflows
• Provide guidance and mentorship to Regulatory Specialist I or newly hired staff as assigned
• Stay current with FDA, OHRP, and ICH-GCP regulatory updates affecting clinical research operations
• Attend departmental and study start-up meetings to provide regulatory status updates and timelines
• Perform other related duties as assigned

Qualifications

• Bachelors degree in Life Sciences, Clinical Research, Science, Healthcare Administration, or a related field
• 2-5 years of regulatory experience in clinical research or pharmaceutical environments
• CITI certifications (GCP, HSC, RCR, COI, IPS, IATA, ICH, CRC) required within two weeks of hire; training will be provided
• Familiarity with IRB submissions, study start-up activities, and regulatory document maintenance
• Proficiency with CRIO (Clinical Research IO) or similar electronic platforms used for eISF and study documentation
• Experience with Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC) platforms, and eISF systems
• Working knowledge of FDA, OHRP, and ICH-GCP guidelines
• Prior experience supporting sponsor or FDA audits/inspections
• Strong organizational, communication, and time-management skills
• Ability to work independently and manage multiple priorities

Technical Skills

• Proficiency in Microsoft Teams, PDF Filler, DocuSign, SharePoint, and CTMS tools
• Demonstrated ability to manage regulatory workflows in electronic systems, particularly CRIO
• Strong attention to detail with the ability to maintain accurate, audit-ready documentation