Regulatory Start-Up Specialist — Hybrid Work & Growth

Ctifacts; Covington, Northern (KY, KY); Hybrid; USD 85,000 - 110,000; Full time

Benefits offered by this job

Hybrid work opportunities

Health benefits

Paid time off

Tuition reimbursement

Job summary

CTI Clinical Trial and Consulting Services, headquartered in the Greater Cincinnati region, seeks a Regulatory Affairs Study Start Up Specialist to manage regulatory documentation for global studies, including IRB/EC submissions and local regulatory requirements. You will coordinate with sponsors, sites, and project teams to ensure timely collection, review, and archiving of essential documents.

The role requires 3–5 years of regulatory experience in pharma/CRO, a health-related degree, and the

Qualifications

• Manage essential regulatory documentation for submission to IRBs/ECs/CA and other regulators.
• Assist project teams on regulatory requirements for clinical studies.
• Review and adapt study documents to country/site requirements.

Responsibilities

• Assist/advise project teams on regulatory requirements for clinical studies
• Perform compliance assessments according to country requirements and document findings
• Review and adapt study documents to country/site requirements
• Perform IRB/EC submissions on behalf of sponsors and sites
• Receive and process study documentation from sites and verify completeness
• Coordinate with site personnel for document corrections and resolutions
• Compile regulatory documentation/timelines per CTI and sponsor SOPs
• Assist with Informed Consent Form adaptations
• Interact with Sponsors and forward regulatory submissions when required
• Prepare for sponsor or agency audits and inspections
• Oversee translation of regulatory documents when needed
• Attend study meetings and regulatory status reports

Skills

Regulatory processes

IRB submissions

Documentation control

Regulatory liaison

Education

Associate’s or Bachelor’s degree in allied health

Tools

Regulatory documentation systems

Job description

CTI Clinical Trial and Consulting Services, headquartered in the Greater Cincinnati region, seeks a Regulatory Affairs Study Start Up Specialist to manage regulatory documentation for global studies, including IRB/EC submissions and local regulatory requirements. You will coordinate with sponsors, sites, and project teams to ensure timely collection, review, and archiving of essential documents.

The role requires 3–5 years of regulatory experience in pharma/CRO, a health-related degree, and the