Clinical Trial Project Lead

ProTrials Research, Inc.; United States; On-site; USD 85,000 - 130,000; Full time

Job summary

ProTrials is seeking a Contract Clinical Project Specialist to coordinate studies from start-up to close-out, partnering with sponsors, sites, and cross-functional teams. You will drive study planning, site activation, TMF quality, and vendor management to ensure deliverables are met.

The ideal candidate has 2-4 years in clinical research, strong organizational skills, and familiarity with FDA regulations, ICH-GCP, and eTMF systems.

Qualifications

• 2-4 years of progressive experience as clinical research professional.
• Ability to lead and coordinate activities and team members.
• Excellent attention to detail and organization.
• Knowledge of FDA regulations and ICH-GCP guidelines.
• Advanced MS Office skills (Word, Excel, PowerPoint).
• Familiarity with electronic TMF (eTMF) systems.

Responsibilities

• Document study plans and update them throughout the project lifecycle.
• Develop and review study documents (Protocol, ICF, CRFs, etc.).
• Oversee feasibility via site capabilities information.
• Lead start-up, site activation, and close-out activities.
• Participate in TMF QC activities and audits for inspection readiness.
• Provide status reports and communicate project progress to sponsors.

Skills

Clinical research

Project coordination

Team leadership

Attention to detail

MS Office

eTMF

Tools

eTMF

Job description

ProTrials is seeking a Contract Clinical Project Specialist to coordinate studies from start-up to close-out, partnering with sponsors, sites, and cross-functional teams. You will drive study planning, site activation, TMF quality, and vendor management to ensure deliverables are met.

The ideal candidate has 2-4 years in clinical research, strong organizational skills, and familiarity with FDA regulations, ICH-GCP, and eTMF systems.