Clinical Trials Regulatory Specialist III

Emory University

. The Regulatory Specialist III is an advanced level position supporting regulatory affairs in clinical trials research.

Posted 4/23/2026full-timeRemote • 🇺🇸 United StatesMid-LevelSeniorWebsite

About the role

Key responsibilities & impact

The Regulatory Specialist III is an advanced level position supporting regulatory affairs in clinical trials research.
Employees in this job class support all trial complexities (basic to multiphase) and manage the study activation process.
Serves as the internal project manager for assigned specific oncology disease group(s), providing the group with timely updates on the status of submissions and regulatory guidance on study development.
Liaison between the sponsor, the investigator, Winship, Emory IRBs, external IRBs and internal departments/staff.
Independently prepare IRB documents, maintain regulatory files, and facilitate regulatory oversight of safety reporting.
In concert with IND Sponsors, prepare and review IND submissions, communicate with the FDA, and prepare for FDA audits.
Responsible for 35+ trial load per year of NCTN, industry and investigator-initiated trials.
Establishes and maintains processes and monitors practices to ensure regulatory documentation involving clinical trials complies with Institutional Review Board (IRB) policies and procedures and regulations.
Reviews processes involving regulatory documentation, including but not limited to NCTN/NCI informed consent review, to assure appropriate timelines are followed.
Maintain study regulatory binders and electronic files in accordance with institutional and sponsor requirements.
Coordinate protocol activation/maintenance process and communicates to allow for enrollment to start and maintain once regulatory documents (e.g. DSMC review) are in place.
Disseminates information and coordinates or conducts training.
Researches and analyzes problems and takes a leadership role in resolving.
Lead study start-up/maintenance: prepare and submit all required regulatory documents for new/current study applications and successfully open/close studies from inception to accrual.
Participates in the development and implementation of standard operating procedures, development and revision of regulatory orientation plans, and orientation and mentorship of newly hired staff.
Actively participates in designated committees within the unit and Emory University.
Direct the clinical team to ensure all facets of each protocol are compliant and fully covered.
Perform internal audit and quality assurance checks on regulatory documents.
Prepare, track and maintain all correspondence and regulatory documentation required by the IRB, FDA, IND Sponsors, and other institutional and federal oversight committees, including drafting and reviewing content as appropriate.

Requirements

What you’ll need

Bachelor's degree and five years of experience in a research environment, or an equivalent combination of experience, education and training.
Knowledge of IRB processes, federal research regulations and a basic understanding of funding programs and clinical research practices.
Must obtain all required training courses within one month of hiring date.
Must possess an applicable research certification within 2 years of hire (i.e. ACRP, SOCRA, RAC etc.).

Benefits

Comp & perks

Emory is an equal opportunity employer
Reasonable accommodations to qualified individuals with disabilities upon request

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory documentationIND submissionssafety reportingclinical trials managementprotocol activationquality assuranceaudit processesIRB document preparationresearch analysisproject management

Soft Skills

leadershipcommunicationproblem-solvingtraining coordinationinterpersonal skillsorganizational skillsmentorshipteam collaborationtime managementdissemination of information

Certifications

ACRPSOCRARAC