Remote Clinical Research Regulatory Specialist

Jobgether; United States; Remote; USD 65,000 - 95,000; Full time

Benefits offered by this job

Remote US work

Professional development

Impactful work

Collaborative culture

Career growth

Purpose-driven culture

Job summary

Jobgether on behalf of a partner company seeks a Clinical Research Regulatory Specialist in the United States to ensure regulatory compliance across trials, manage IRB submissions, study records, and investigator credentials, and support regulatory quality assurance.

You will collaborate with investigators, sponsors, CROs, and staff to maintain ISFs, prepare continuing reviews, and support startup activities using Florence eRegulatory.

Qualifications

• High school diploma or equivalent required; a bachelor’s degree is preferred.
• 1–2 years of clinical research experience, preferably with regulatory affairs or quality assurance.
• Current Good Clinical Practice (GCP) certification.
• Relevant licenses or CEUs, where applicable.
• Strong understanding of medical terminology and clinical research processes.
• Familiarity with ICH/GCP guidelines, FDA regulations, and HIPAA policies.

Responsibilities

• Coordinate study startup activities, including IRB submissions and regulatory documentation.
• Support Florence eRegulatory platform by creating electronic study binders and filing documents.
• Prepare and maintain essential regulatory documents (FDFs, PSPs, 1572s, ISF pages).
• Distribute regulatory docs to investigators and staff for review and signatures; monitor deadlines.
• Submit regulatory documentation to sponsors/CROs within deadlines.
• Maintain delegation of authority and training logs.
• Review ISFs for completeness and regulatory compliance.
• Assist with Site Selection Visits and investigator credentialing.
• Prepare investigator CVs and coordinate updates; obtain licenses for investigators.
• Prepare continuing reviews and protocol deviations for IRB submissions.
• Contribute to SOPs and Guidance Documents; perform other regulatory duties.

Skills

Regulatory documentation

IRB submissions

Attention to detail

Communication

Education

High school diploma or equivalent

Bachelor's degree preferred

Tools

Florence eRegulatory

Microsoft Excel

Adobe Acrobat

Job description

Jobgether on behalf of a partner company seeks a Clinical Research Regulatory Specialist in the United States to ensure regulatory compliance across trials, manage IRB submissions, study records, and investigator credentials, and support regulatory quality assurance.

You will collaborate with investigators, sponsors, CROs, and staff to maintain ISFs, prepare continuing reviews, and support startup activities using Florence eRegulatory.