Remote Study Start-Up & Essential Documents Specialist

iuvo BioScience, llc.; United States; Remote; USD 110,000 - 140,000; Full time

Benefits offered by this job

Remote work

Video-first environment

Disability accommodation

Job summary

iuvo Clinical, a full-service ophthalmology-focused CRO, is seeking a Contractor Study Startup & Essential Documents Specialist for a six-month engagement. You will support site start-up activities, manage essential documents, and handle Central IRB submissions to ensure study readiness across sites.

The role requires strong regulatory document handling, eTMF experience, and the ability to work with sponsor specifications while coordinating with internal teams and investigative sites.

Qualifications

• Bachelor’s degree or equivalent; clinical site management experience preferred.
• Experience collecting, reviewing, and submitting regulatory documents with investigational sites preferred.
• Experience in ophthalmology is advantageous.
• Strong communication and coordination skills with internal and external teams.

Responsibilities

• Manage study-level essential documents from start-up to close-out, including IRB activities.
• Oversee Central IRB management for project and site levels.
• Support development of ICF and patient-facing materials for IRB submissions.
• Serve as primary contact for study start-up with assigned sites.
• Ensure eTMF readiness and track documents per TMF plan.
• Coordinate with internal/external teams for audits and updates.
• Escalate site issues to project teams as needed.
• Read and adhere to SOPs and client requirements.

Skills

Clinical site management

Ophthalmology experience

Regulatory document handling

IRB submissions

Clear communication

Education

Bachelor’s degree or equivalent

Tools

Veeva QC

Agatha

eTMF systems

Document processing in Veeva

Index creation and maintenance

Microsoft Office

Job description

iuvo Clinical, a full-service ophthalmology-focused CRO, is seeking a Contractor Study Startup & Essential Documents Specialist for a six-month engagement. You will support site start-up activities, manage essential documents, and handle Central IRB submissions to ensure study readiness across sites.

The role requires strong regulatory document handling, eTMF experience, and the ability to work with sponsor specifications while coordinating with internal teams and investigative sites.