Clinical Study Coordinator - TMF/CTMS & Regulatory Docs

Real; Warsaw (IN); On-site; USD 42,000 - 62,000; Full time

Job summary

Real is seeking a detail-oriented administrative coordinator to support clinical studies. You will work with study teams to maintain CTMS data, prepare regulatory binders, and ensure the Trial Master File is complete in accordance with regulations and guidelines.

Satisfactory candidates will have a Bachelor's degree, experience with Veeva CTMS and TMF, prior clinical research or admin support, and proficiency with Microsoft Office.

Qualifications

• Bachelor's degree required or preferred.
• Experience with Veeva CTMS/TMF is expected.
• Clinical research experience is a plus.
• Administrative support experience (min 1 year) required.
• Microsoft Office proficiency (Excel, Word, PowerPoint).

Responsibilities

• Maintain CTMS data with study teams and partners.
• Create and distribute regulatory binders.
• Track essential documents and ensure TMF completeness.
• Distribute safety documentation for audits or meetings as needed.
• Create and generate system reports.
• Support study supplies creation, ordering, and distribution to sites.
• Assist with device tracking and ordering if applicable.

Skills

CTMS experience

TMF management

Clinical research

Administrative support

Microsoft Office

Veeva

Excel

PowerPoint

Word

Education

Bachelor's Degree

Tools

Veeva CTMS

Microsoft Office

Job description

Real is seeking a detail-oriented administrative coordinator to support clinical studies. You will work with study teams to maintain CTMS data, prepare regulatory binders, and ensure the Trial Master File is complete in accordance with regulations and guidelines.

Satisfactory candidates will have a Bachelor's degree, experience with Veeva CTMS and TMF, prior clinical research or admin support, and proficiency with Microsoft Office.