Senior Study Start-Up & Regulatory Submissions Coordinator

Medpace; Cincinnati (OH); On-site; USD 60,000 - 90,000; Full time

Job summary

Medpace in Cincinnati, OH is seeking a full-time, office-based Regulatory Submissions Coordinator to contribute to the Study Start-up team. You will work independently and with a team to gather and submit regulatory documents, coordinate with sites, IRBs, and internal stakeholders to keep trials on schedule.

The role requires a bachelor's degree in life sciences and 1–5+ years in study start-up or pharma; strong attention to detail, organization, and communication; familiarity with TMF and

Qualifications

• Bachelor's degree in Life Sciences required.
• 1–5+ years of study coordinator or pharma industry start-up experience.
• Excellent organizational and prioritization skills.
• Knowledge of Microsoft Office tools (Word, Excel, PowerPoint).
• Strong oral and written communication skills.

Responsibilities

• Communicate with sites to collect essential documents before screening.
• Maintain and review Trial Master File (TMF) documents.
• Collect, review, and assemble regulatory start-up submissions (IRB submissions, etc.).
• Maintain timelines for study start-up with internal and external teams.
• Advise internal/external stakeholders to ensure regulatory compliance.
• Review regulations to develop proactive solutions to regulatory challenges.

Skills

Regulatory knowledge

Study Start-up

TMF management

Document review

Communication

Education

Bachelor's degree in Life Sciences

Tools

Microsoft Office

Job description

Medpace in Cincinnati, OH is seeking a full-time, office-based Regulatory Submissions Coordinator to contribute to the Study Start-up team. You will work independently and with a team to gather and submit regulatory documents, coordinate with sites, IRBs, and internal stakeholders to keep trials on schedule.

The role requires a bachelor's degree in life sciences and 1–5+ years in study start-up or pharma; strong attention to detail, organization, and communication; familiarity with TMF and