Clinical Research Regulatory Specialist

Clinical Research Regulatory Specialist

Remote – U.S.-Based \| Full-Time

About Folio Clinical Research

Folio Clinical Research is a leading urologic research network treating urologic cancers, urinary stones, Peyronie's disease, sexual and erectile dysfunction (ED), low testosterone, prostate disorders, urinary incontinence, and more. We partner with leading physician practices to create a cohesive, quality-oriented clinical culture, facilitating best practice sharing across our platform. Our affiliated practices gain access to a broad suite of clinical trials, providing significant benefits to both physicians and patients.

Position Overview

The Regulatory Specialist is responsible for managing all regulatory documentation and ensuring that site-level trial activities comply with ICH/GCP guidelines, FDA and local regulations, and IRB requirements across Folio's clinical research sites. Working remotely in close partnership with Principal Investigators, CRC teams, and Regional Managers, this role owns the electronic Investigator Site File (eISF) and end-to-end regulatory processes from Site Qualification through Study Close-out.

This role is a strong fit for an experienced CRC who has developed deep regulatory expertise and is ready to step into a dedicated regulatory function, or for a regulatory professional earlier in their career who wants focused ownership and a clear path to grow within a site network environment. If you are energized by documentation precision, audit readiness, and being the regulatory backbone of a high-performing research team — this role is for you.

Key Responsibilities

• Manage all regulatory documentation in support of the PI/SI, APPs, research staff, and CRCs, ensuring compliance with ICH/GCP guidelines, FDA regulations, and IRB requirements.
• Own the electronic Investigator Site File (eISF/eRegulatory) — maintaining completeness, accuracy, and audit-readiness throughout the trial lifecycle from Site Qualification to Study Close-out.
• Prepare and submit IRB applications, amendments, continuing reviews, safety reports, and other required regulatory correspondence.
• Maintain staff delegation logs, training records, CVs, medical licenses, and personnel documents for all site staff listed on study protocols.
• Attend SQVs, SIVs, and interim monitoring visits (IMVs) remotely to ensure regulatory tasks are tracked, communicated, and resolved in a timely manner.
• Lead preparation and follow-through for internal and external monitoring visits and audits; ensure all trial activities meet protocol, ICH/GCP, and SOP standards.
• Lead training for site staff on regulatory requirements, documentation standards, and updated SOPs; ensure all personnel maintain current training records and certifications.
• Partner with the CRC team and site leadership to align regulatory timelines with study startup, enrollment, and close-out milestones.
• Identify regulatory risks and documentation gaps proactively; communicate findings to site leadership with recommended corrective actions.
• Support the PI, CRCs, and Regional Managers with the overall growth of the clinical research program; define and achieve regulatory KPIs that drive company milestones while maintaining a culture of accountability.
• Ensure adherence to GCP, Good Documentation Standards, ALCOA-C\+\+, and IRB protocols and all applicable laws and policies governing the industry.

Qualifications

Please note: This role requires experience in industry-sponsored clinical trials governed by FDA regulations. Candidates whose background is primarily in investigator-initiated trials, NIH-funded studies, or non-FDA-regulated academic research should note that this experience does not meet the requirements of this position.

• 2–3 years of experience in a role where FDA-regulated, site-level regulatory coordination was a primary function — including hands-on responsibility for eISF/ISF management, IRB submissions, and sponsor/CRO-facing documentation on industry-sponsored pharma, biotech, or medical device clinical trials. General CRC experience where regulatory tasks were incidental to broader study coordination does not meet this requirement. Experience limited to investigator-initiated trials, NIH/academic research, or non-FDA-regulated studies does not qualify for this role.
• Bachelor's degree or equivalent combination of education and experience in a science, health, or related field.
• Working knowledge of ICH-GCP guidelines and FDA regulations (21 CFR Parts 11, 50, 56, 312) as they apply to industry-sponsored trials.
• Demonstrated proficiency with eISF/eRegulatory systems; understanding of how site-level regulatory files interface with sponsor-side eTMF platforms during monitoring and audits.
• Experience with a Clinical Trial Management System (CTMS); familiarity with CRIO a plus, as the regulatory team leads site-wide CRIO implementation.
• Strong organizational, documentation, and communication skills; able to manage multiple concurrent studies and interface independently with sponsors, monitors, and IRBs.

Preferred Qualifications

• Experience in a dedicated regulatory role at a clinical research site, SMO, central/independent IRB, or CRO site activation/startup function.
• Experience in urology, oncology, or a related therapeutic area.
• Medical device trial experience; familiarity with IDE regulations beneficial.
• Certification in clinical research: CCRC, CCRP (ACRP or SOCRA), or equivalent.
• Experience supporting FDA inspections or sponsor audits.

Any data provided as a part of this application will be stored in accordance with our Policy.

Folio Clinical Research is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

Pay: $65,000\.00 - $85,000\.00 per year

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Education:

• Bachelor's (Preferred)

Experience:

• clinical research regulatory or coordinating: 3 years (Preferred)
• industry-sponsored (pharma/biotech/medical device) trials: 3 years (Preferred)

Work Location: Remote