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How much do clinical research regulatory jobs pay per hour?

As of Aug 11, 2026, the average hourly pay for clinical research regulatory in the United States is $41.13, according to ZipRecruiter salary data. Most workers in this role earn between $28.85 and $52.64 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in clinical research regulatory?

To thrive as a Clinical Research Regulatory professional, you need a solid understanding of clinical research processes, regulatory requirements, and compliance standards, often backed by a degree in life sciences or a related field. Familiarity with regulatory submission systems (such as IRB portals), document management tools, and certifications like RAC (Regulatory Affairs Certification) are highly valued. Detail orientation, effective communication, and problem-solving abilities are vital for managing complex documentation and coordinating with diverse teams. These skills enable safe, compliant, and efficient clinical research studies in a highly regulated environment.

What is a clinical research regulatory?

A Clinical Research Regulatory job involves ensuring that clinical trials comply with regulatory requirements, ethical guidelines, and institutional policies. Professionals in this role prepare and submit regulatory documents, liaise with regulatory agencies, and maintain compliance throughout the study. They work closely with clinical teams, sponsors, and ethics committees to ensure research integrity and patient safety. Strong knowledge of FDA regulations, ICH-GCP guidelines, and institutional review board (IRB) processes is essential.

Is clinical research regulatory an entry level job?

Clinical research regulatory roles can be entry-level, especially for positions such as Regulatory Assistants or Coordinators, which often require a bachelor's degree and some familiarity with regulations like GCP or FDA guidelines. However, more senior roles typically require additional experience or specialized certifications, such as RAC (Regulatory Affairs Certification).

What are some common challenges faced by clinical research regulatory professionals?

Clinical Research Regulatory professionals often face the challenge of navigating complex and evolving regulations while ensuring timely and accurate submission of documentation for clinical trials. Keeping up-to-date with global regulatory changes and managing tight deadlines can be demanding, especially when supporting multiple studies simultaneously. Strong collaboration with clinical, legal, and quality assurance teams is essential to address compliance issues and resolve ambiguities. Adapting to shifting priorities and maintaining meticulous attention to detail are also crucial for success in this role.

What does a clinical research regulatory specialist do?

A clinical research regulatory specialist ensures that clinical trials comply with government regulations and guidelines. They prepare and review documentation, submit regulatory approvals, and coordinate with oversight agencies to facilitate trial approval and conduct. Strong knowledge of regulations such as FDA or EMA requirements and attention to detail are essential in this role.
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Clinical Research Regulatory jobs near you
Infographic showing various Clinical Research Regulatory job openings in the United States as of August 2026, with employment types broken down into 3% As Needed, 71% Full Time, 18% Part Time, and 8% Contract. Highlights an 95% Physical, 1% Hybrid, and 4% Remote job distribution, with an average salary of $85,542 per year, or $41.1 per hour.

Clinical Research Regulatory Specialist

OneOncology

Charleston, WV • Remote

Full-time

Re-posted 28 days ago

OneOncology rating

7.8

Company rating: 7.8 out of 10

Based on 17 frontline employees who took The Breakroom Quiz

Job description

OneOncology is positioning community oncologists to drive the future of medical care through a patient-centric, physician-driven, and technology-powered model to help improve the lives of everyone living with cancer and other diseases. Our team is bringing together leaders to the market place to help drive OneOncology's mission and vision.

Why join us? This is an exciting time to join OneOncology. Our values-driven culture reflects our startup enthusiasm supported by industry leaders in oncology, urology, technology, and finance. We are looking for talented and highly-motivated individuals who demonstrate a natural desire to improve and build new processes that support the meaningful work of independent physicians and the patients they serve.

Job Description:

The Clinical Research Regulatory Specialist will collaborate with OneR operations team and OneOncology practices to support clinical research across the OneOncology network. The Clinical Research Regulatory Specialist will play a crucial role in ensuring compliance with regulatory requirements and guidelines for our clinical research projects. The Clinical Research Regulatory Specialist will work closely with cross-functional teams to facilitate the regulatory aspects of clinical trials, ensuring smooth and efficient processes from study initiation through to completion. Additionally, they will engage with various practices within our network to streamline regulatory processes and foster collaboration.

Responsibilities

  • Ensure adherence to all relevant regulatory requirements, including FDA regulations, ICH guidelines, and local regulatory requirements.

  • Prepare, submit, and maintain regulatory documents, such as investigational new drug (IND) applications, amendments, and annual reports.

  • Coordinate regulatory submissions to regulatory authorities and ethics committees, ensuring timely and accurate completion.

  • Assist in the review of clinical trial protocols, informed consent forms, and other study-related documents to ensure compliance with regulatory standards.

  • Review and modify study specific informed consent forms for readability, clarification of payments, costs, and standard of care language, and to ensure that all elements required by the Food and Drug Administration (FDA) are included.

  • Prepare, route, and submit essential regulatory documents to sponsors/CROs on behalf of network practices.

  • Collaborate with investigators and study teams to address regulatory issues and provide guidance on regulatory requirements.

  • Coordinate regulatory activities during study start-up, including obtaining regulatory approvals, organizing regulatory binders, and ensuring site compliance with regulatory requirements.

  • Maintain accurate and up-to-date regulatory files and documentation, ensuring completeness and compliance with regulatory standards.

  • Establish and maintain an electronic regulatory binder system to securely store and manage regulatory documents and submissions.

  • Track and communicate regulatory submission timelines, milestones, and status updates to internal stakeholders.

  • Provide training and support to study teams and investigators on regulatory requirements, procedures, and best practices.

  • Stay informed about changes in regulatory requirements and industry standards, and disseminate relevant information to team members.

  • Cultivate and maintain relationships with various practices within our network to streamline regulatory processes and promote collaboration.

  • Other duties as assigned to help drive our mission of improving the lives of everyone living with cancer.

Key Competencies

  • Strong understanding of clinical trial processes, regulatory requirements (e.g., ICH-GCP, FDA guidelines), and industry standards

  • Exceptional attention to detail and organizational skills

  • Effective communication and interpersonal skills, with the ability to collaborate across multidisciplinary teams

  • Ability to work independently and collaboratively in a fast-paced environment

Qualifications

  • Bachelor's degree in a relevant field (e.g., life sciences, pharmacy, nursing) required; advanced degree preferred

  • Minimum of 1-2 years of experience in clinical research, with a focus on regulatory affairs and compliance

  • Proficiency in Microsoft Office applications and familiarity with electronic data capture (EDC) systems, electronic regulatory binder system, and clinical trial management systems (CTMS) preferred

  • Certification in clinical research (e.g., SoCRA, ACRP) is a plus.

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