Clinical Trials Project Lead

ProTrials Research, Inc.; United States; Remote; USD 80,000 - 100,000; Full time

Job summary

ProTrials is a women-owned CRO seeking a Contract Clinical Project Specialist to coordinate clinical trials from start-up to close-out, partnering with project leadership, sponsors, sites, and cross-functional teams.

The role combines hands-on study coordination with project oversight, supporting study planning, site activation, TMF quality, vendor management, and tracking critical deliverables.

Qualifications

• 2-4 years of progressive experience as clinical research professional.
• Ability to lead and coordinate activities and team members, as needed.
• Exceptional attention to details.
• Knowledge of FDA regulations and ICH-GCP Guidelines.
• Advanced proficiency in MS Office (Word, Excel, PowerPoint) and eTMF.

Responsibilities

• Document study plans for distribution to the team, sponsor, and ProTrials management.
• Develop and/or review study documents, including Protocol, Investigator Brochure, ICF, CRFs, Operations Manual, study aids, and site budget.
• Oversee and support the feasibility process via collection and review of site capabilities information.
• Proactively manage, review, and approve essential study documents to obtain site activation.
• Lead study start-up and site close-out activities, including organization and mentorship of staff.
• Participate in TMF QC activities and audits: supervise TMF activities and ensure inspection readiness.
• Schedule and attend regular team meetings to track progress and action items.
• Provide status reports to sponsor, team, and ProTrials management; disseminate information to sites.
• Keep project leadership and CRA/CTA team apprised of site and study status.
• Manage outside vendors and their deliverables (CROs, DM groups, labs).
• Ensure compliance with FDA, ICH-GCP, and SOPs; support investigator screening.
• Resource planning, tracking deliverables, and data collection as needed.

Skills

Clinical research

Project coordination

Team leadership

Attention to detail

FDA regulations

Tools

MS Office

eTMF

Job description

ProTrials is a women-owned CRO seeking a Contract Clinical Project Specialist to coordinate clinical trials from start-up to close-out, partnering with project leadership, sponsors, sites, and cross-functional teams.

The role combines hands-on study coordination with project oversight, supporting study planning, site activation, TMF quality, vendor management, and tracking critical deliverables.