Clinical Study Administrator

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

Deliverables

• Work with Study Teams and partners to maintain and track relevant activities in CTMS.
• Creation/distribution of regulatory binders
• Timely tracking of study essential documents and ensuring completeness of the Trial Master File for assigned clinical studies according to appropriate regulations, departmental guidelines, and work instructions.
• Distribution of safety documentation to other functional groups in support of safety committee meetings as requested (supporting role).
• Creation and generation of system reports.
• Provide support for study supplies creation, ordering and distribution to the sites e.g. print protocols, burn DVDs
• Assist with Device tracking and ordering if required and if applicable.

Desired Skills and Experience

Education and Experience Guidelines

• Minimum of a Bachelor's Degree is preferred.
  . Experience with Veeva as CTMS and TMF
• Previous clinical research experience a plus.
• Requires previous administrative support experience or equivalent for at least 1 year.
• Clinical/medical background a plus.
• Requires experience and knowledge working with computer systems (Microsoft office - Excel, Word and
  Power Point).

Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.