Clinical Project Specialist - Contract Position

About the Role

The Contract Clinical Project Specialist plays a key role in the successful execution of clinical trials, partnering closely with project leadership, sponsors, sites, and cross-functional study teams from start-up through close-out. This position combines hands-on study coordination with project oversight, supporting study planning, site activation, TMF quality and inspection readiness, vendor management, and the tracking of critical project deliverables.

Responsibilities

• Document study plans for distribution to the team, sponsor, and ProTrials management. Review and update study plans throughout the project lifecycle.
• Develop and/or review study documents, including Protocol, Investigator Brochure, ICF, CRFs, Operations Manual, study aids, and site budgets.
• 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 strategic organization and execution of tasks, as well as lead and/or mentor staff assisting with site activations and closures.
• Participate in TMF QC activities and audits: supervise TMF activities, coordinate inspection readiness, and conduct TMF quality control reviews according to study plans.
• Schedule and attend regular team meetings, provide meeting agendas, transcribe or review meeting minutes, newsletters, and mass site communications, and track action items.
• Provide status reports to sponsors, teams, and ProTrials management, and disseminate documents/information to study sites.
• Keep project leadership and CRA/CTA teams informed of site and study status.
• Participate in the selection and management of outside vendors and their deliverables.
• Ensure compliance with local regulations, FDA/ICH-GCP guidelines, and ProTrials and sponsor SOPs.
• Support investigator screening and selection activities.
• Mentor CTA team members, monitor progress, and provide feedback on goals and deliverables.
• Update project management on progress, resource needs, sponsor issues, and team performance.
• Run and review time code billing, provide feedback on trends, and track site invoices and payments.
• Contribute to Regulatory Authority Inspection Teams, attend mock inspections/audits, and participate in regulatory inspections as required.

Requirements

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

Qualifications

The ideal candidate is a proactive, highly organized clinical research professional who enjoys managing complex studies, anticipating needs, and fostering team collaboration.