Remote Clinical Trials Regulatory Specialist

Jobgether; Oregon; Hybrid; USD 60,000 - 90,000; Full time

Benefits offered by this job

Remote work within the United States

Professional development

Meaningful impact

Collaborative environment

Job summary

Jobgether seeks a Clinical Research Regulatory Specialist based in the United States to oversee regulatory submissions, essential study records, investigator credentials, and ongoing documentation for clinical trials.

The role involves coordinating IRB submissions, managing eRegulatory documentation, and ensuring ISF compliance, with exposure to CROs and sponsors. Strong communication and attention to detail are essential.

Qualifications

• Required: High school diploma or equivalent; preferred: bachelor's degree.
• 1-2 years clinical research experience, regulatory focus preferred.
• Current Good Clinical Practice (GCP) certification; CEUs where applicable.

Responsibilities

• Coordinate study startup activities including IRB submissions and regulatory documentation.
• Maintain electronic regulatory systems and document management (eRegulatory platform).
• Prepare and submit regulatory documents to sponsors and CROs on time.
• Ensure Investigator Site Files (ISFs) are complete and compliant with regulatory standards.
• Support regulatory quality assurance and study startup/maintenance activities.

Skills

Communication

Interpersonal skills

Attention to detail

Time management

Education

Bachelor's degree preferred

High school diploma required

Tools

Microsoft Excel

Adobe Acrobat

MS Office

Job description

Jobgether seeks a Clinical Research Regulatory Specialist based in the United States to oversee regulatory submissions, essential study records, investigator credentials, and ongoing documentation for clinical trials.

The role involves coordinating IRB submissions, managing eRegulatory documentation, and ensuring ISF compliance, with exposure to CROs and sponsors. Strong communication and attention to detail are essential.