Study Start-Up Specialist: Regulatory Submissions

Medpace; Irving (TX); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Comprehensive health benefits

Office-based with on-site mentors

Defined career paths and onboarding

Job summary

Medpace is seeking a Regulatory Submissions Coordinator for the Study Start-up team in a full-time, office-based role in Dallas, TX. The position involves coordinating with sites to collect essential documents, managing TMF quality, and assembling regulatory submissions for IRBs and other authorities.

Ideal candidates have a life sciences degree and 1-5+ years’ study start-up or pharmaceutical experience, with strong organizational and communication skills and proficiency in Microsoft Office.

Qualifications

• Bachelor's degree required, preferably in Life Sciences.
• 1-5+ years of prior experience as a study coordinator or within the pharmaceutical industry, study start-up experience preferred.
• Excellent organization and communication skills; and
• Knowledge of Microsoft Office.

Responsibilities

• Communicate with research sites to collect essential documents before screening.
• Maintain and perform ongoing quality review of trial documents in TMF.
• Collect, review, organize, and assemble regulatory start-up submissions (IRB submissions included).
• Maintain timelines for study start-up through internal and external collaboration.
• Provide advice and guidance to team members to ensure regulatory compliance.
• Review regulations and guidance to develop proactive regulatory solutions.

Skills

Regulatory submissions

Study start-up

Documentation management

Education

Bachelor's degree

Tools

Microsoft Office

Job description

Medpace is seeking a Regulatory Submissions Coordinator for the Study Start-up team in a full-time, office-based role in Dallas, TX. The position involves coordinating with sites to collect essential documents, managing TMF quality, and assembling regulatory submissions for IRBs and other authorities.

Ideal candidates have a life sciences degree and 1-5+ years’ study start-up or pharmaceutical experience, with strong organizational and communication skills and proficiency in Microsoft Office.