Strategic Regulatory Study Start-Up Specialist

CTI Clinical Trial and Consulting Services, Inc.; Cincinnati (OH); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Hybrid work opportunities

Paid parental leave

Health benefits

Job summary

CTI Clinical Trial and Consulting Services, Inc. is seeking a Regulatory Affairs Study Start Up Specialist (level dependent on experience) to manage essential regulatory documentation for global clinical studies and to support timely submissions to IRBs, ECs, and Competent Authorities.

You’ll interact with study teams, sites, sponsors and CTI management to collect, review, reconcile, and archive documentation, perform QC checks, adapt informed consent forms, and provide ongoing status updates.

Qualifications

• Knowledge of regulatory documentation practices for global clinical studies.
• Ability to interpret country requirements and ensure compliant submissions.
• Experience with IRB/EC/CA submissions and study documentation QC.

Responsibilities

• Assist/regulatory submissions for IRB/EC/CA as applicable.
• Review and adapt study documents per country/site requirements.
• Maintain regulatory TMF and archive study materials.
• Prepare ICFs and adapt as per regulatory requests.
• Provide status updates and reports to sponsors and CTI management.

Skills

Regulatory knowledge

Attention to detail

Communication

Education

Associate’s or Bachelor’s degree in allied health

Job description

CTI Clinical Trial and Consulting Services, Inc. is seeking a Regulatory Affairs Study Start Up Specialist (level dependent on experience) to manage essential regulatory documentation for global clinical studies and to support timely submissions to IRBs, ECs, and Competent Authorities.

You’ll interact with study teams, sites, sponsors and CTI management to collect, review, reconcile, and archive documentation, perform QC checks, adapt informed consent forms, and provide ongoing status updates.