Global Regulatory Start-Up Specialist — Clinical Trials

CTI Clinical Trial and Consulting Services; Covington (KY); Vor Ort; USD 60.000 - 90.000; Vollzeit

Benefits dieser Stelle

Hybrid work from home

Health benefits

Zusammenfassung

CTI Clinical Trial and Consulting Services is seeking a regulatory professional to manage essential regulatory documentation for global clinical studies. You will support project teams, perform country-specific compliance assessments, and coordinate IRB/EC submissions with sponsors and sites.

The role requires 3–5 years of regulatory experience in pharma/CRO settings, with strong cross-functional collaboration and attention to detail. On-site work in Covington, KY is expected.

Qualifikationen

• Associate’s or Bachelor’s degree in allied health field or life sciences.
• 3–5 years of pharmaceutical/site/CRO regulatory experience.

Aufgaben

• Assist project teams on regulatory requirements for clinical studies.
• Perform compliance assessments per country requirements and notify PMs.
• Review and adapt study documents for country/site requirements.
• Submit IRB/EC (CA) submissions on behalf of sponsors/sites per country.
• Receive, check content and quality of study documentation from sites.
• Interact with site personnel to correct or clarify incomplete documentation.
• Compile regulatory documentation/timelines per CTI and sponsor SOPs.
• Assist with ICF preparation and site-adapted ICF according to local rules.
• Support sponsor audits and QA of regulatory documents.

Kenntnisse

Regulatory knowledge

IRB/EC submissions

Cross-functional collaboration

Ausbildung

Life sciences degree

Jobbeschreibung

CTI Clinical Trial and Consulting Services is seeking a regulatory professional to manage essential regulatory documentation for global clinical studies. You will support project teams, perform country-specific compliance assessments, and coordinate IRB/EC submissions with sponsors and sites.

The role requires 3–5 years of regulatory experience in pharma/CRO settings, with strong cross-functional collaboration and attention to detail. On-site work in Covington, KY is expected.