Regulatory Operations Assistant

About the role

The position involves close coordination with investigators, study teams, monitors, institutional review boards, sponsors, and contract research organizations. You will manage regulatory submissions, study logs, training records, safety reports, investigator credentials, and other critical documentation.

Responsibilities

• Maintain paper and electronic Investigator Site Files (ISFs) for assigned investigational drug studies, including IRB submissions and approvals, study documents, correspondence, and other essential records.
• Create, update, review, and finalize Delegation of Authority logs and related systems to accurately reflect study staff changes throughout the study lifecycle.
• Obtain investigator signatures on protocols, amendments, Investigator’s Brochures, logs, and other required study-specific documents and distribute completed documentation to the appropriate sponsor or CRO contacts.
• Receive, review, process, submit, and file IND Safety Reports, SUSAR reports, and other interim safety reports with the appropriate IRB and study files.
• Cook up monitor visits by providing access to study files, maintaining Monitor Visit Logs when applicable, supporting monitors during visits, and updating relevant study systems when monitor assignments change.
• Coordinate monitor visits by providing access to study files, maintaining Monitor Visit Logs when applicable, supporting monitors during visits, and updating relevant study systems when monitor assignments change.
• Process incoming monitor letters, route documents for investigator signatures when required, and ensure appropriate filing within the ISF.
• Maintain training documentation, including protocol-specific, EDC, and CITI training records.
• Track investigator and study staff CVs, licenses, certifications, and other required credentials.
• Manage CITI training completion by sending renewal reminders and following up with study personnel until requirements are satisfied.
• Intake revised study documents such as amendments, protocol letters, notes to file, and Investigator’s Brochures and coordinate their preparation for IRB submission.
• Stamp and file revised documents, update electronic repositories and databases, notify study teams, maintain document tracking spreadsheets, and create or update tasks in OnCore as needed.
• Complete and coordinate investigator signatures for updated Form FDA 1572s and Financial Disclosure Forms.
• Maintain laboratory certifications and normal ranges associated with laboratories listed on Form FDA 1572s, including tracking CVs and licenses for laboratory directors.
• Prepare study files for archiving by conducting final quality assurance checks and verifying that required documentation and records are complete and properly inventoried.
• Support regulatory documentation throughout the study lifecycle while maintaining accuracy, confidentiality, timeliness, and compliance with applicable requirements.

Requirements

• A high school diploma or equivalent is required.
• Demonstrate proficient working knowledge of Microsoft Word and strong general computer skills.
• Possess excellent organizational skills and the ability to manage multiple documentation-related tasks while meeting deadlines.
• Be highly detail-oriented with strong spelling, writing, composition, proofreading, and document-review skills.
• Demonstrate the ability to understand instructions, work independently with minimal supervision, compose professional reports and correspondence, and follow established processes accurately.
• Communicate clearly and professionally with investigators, study teams, monitors, sponsors, CROs, and other stakeholders.
• Demonstrate reliability, strong follow-through, and a proactive approach to completing time-sensitive regulatory activities.
• Be comfortable spending extended periods sitting, typing, and working at a computer.

Benefits

• $22–$24 per hour for this remote position, with actual compensation potentially varying based on market location, job-related knowledge, skills, and experience.
• Full-time, remote work opportunity.
• Monday–Friday schedule, 8:00 AM–4:30 PM EST.
• 401(k) retirement savings plan with employer match.
• Eligibility for an annual performance bonus based on role and organizational results.
• Grossly paid time off and paid holidays.
• Comprehensive medical, dental, and vision coverage, plus optional insurance plans.
• Company-paid life and disability insurance.
• Employee Assistance Program (EAP) providing confidential support for employees and their families from day one.
• Flexible FSA and HSA plans to support financial wellness.
• Suitable and flexible work environment that values employee wellbeing and work-life balance.
• Opportunities for continuous learning, professional growth, collaboration, and contribution within a mission-driven clinical research environment.

Pay

$22–$24 per hour for this remote position, with actual compensation potentially varying based on market location, job-related knowledge, skills, and experience.

Schedule

Full-time, remote work opportunity. Monday–Friday schedule, 8:00 AM–4:30 PM EST.