Remote Regulatory Operations Specialist - Flexible Schedule

The START Center for Cancer Research; United States; Remote; USD 34,000 - 39,000; Full time

Benefits offered by this job

Health coverage

401(k) plan with employer matching

Paid time off and flexible schedule

Remote work options

Job summary

The START Center for Cancer Research is seeking a Regulatory Operations Specialist (Remote) to prepare and submit regulatory documents for new and existing oncology trials. You will coordinate IRB, IBC, and FDA interactions, maintain ISF, and ensure timely status reporting from START USA sites.

This role emphasizes strong regulatory know-how and excellent document management. Collaborate with Sponsor/CRO teams, monitor submissions, and respond to inquiries to keep studies on track.

Qualifications

• High School Diploma or GED required.
• 5 years of experience in a regulatory research setting.
• Proficient with Microsoft Outlook 365.
• Experience with regulatory document management systems (e.g., Veeva, Advarra E-Reg).
• Strong organizational skills and ability to manage timelines in projects.
• Strong knowledge of medical and clinical research terminology.

Responsibilities

• Prepare and submit new studies to IRB, with supervision, drafting informed consent as needed.
• Submit study documents to IRB for assigned studies and maintain ISF; serve as primary IRB contact.
• Prepare and submit documents to IBC under supervision and maintain tracking reports.
• Prepare and submit Expanded Access Studies to FDA and coordinate with IRB/FDA contacts.
• Maintain Investigator Site Files (ISF) for assigned studies.

Skills

Regulatory research

Organizational skills

Medical terminology

Education

High School Diploma/GED

Bachelor's degree

Tools

Veeva

Advarra E-Reg

Microsoft Outlook 365

Job description

The START Center for Cancer Research is seeking a Regulatory Operations Specialist (Remote) to prepare and submit regulatory documents for new and existing oncology trials. You will coordinate IRB, IBC, and FDA interactions, maintain ISF, and ensure timely status reporting from START USA sites.

This role emphasizes strong regulatory know-how and excellent document management. Collaborate with Sponsor/CRO teams, monitor submissions, and respond to inquiries to keep studies on track.