Clinical Project Specialist - Contract Position

2 hours, 31 minutes ago
Contract
Mid Level
Project and Program Management
ProTrials Research,

ProTrials Research,

ProTrials Research, Inc. | Full Service CRO | CRO Services Woman Owned CRO, full service clinical research organization for medical device & diagnostics, and pharmaceutical & biotechnology industries. ProTrials provides clinical operations professional...

Professional Services
51-200
Founded 1996

Description

  • Document, maintain, and distribute study plans throughout the project lifecycle.
  • Develop and review study documents, including protocols, investigator brochures, informed consent forms, CRFs, operations manuals, study aids, and site budgets.
  • Coordinate feasibility, investigator screening, site selection, activation, and close-out activities.
  • Oversee TMF activities, quality control reviews, inspection readiness, audits, and deliverable quality.
  • Track study progress, deliverables, action items, site status, resource needs, out-of-scope work, clinical supplies, and data collection.
  • Prepare status reports and communications for sponsors, study teams, management, and sites.
  • Select and manage external vendors and their deliverables.
  • Ensure compliance with local regulations, FDA requirements, ICH-GCP guidelines, and company and sponsor SOPs.
  • Mentor CTA team members and provide feedback on goals, performance, and deliverables.
  • Review time-code billing, site invoices, and payments, and report trends or issues to the project team.

Requirements

  • 2–4 years of progressive experience as a clinical research professional.
  • Ability to lead, coordinate, and oversee study activities and team members.
  • Exceptional attention to detail.
  • Knowledge of FDA regulations and ICH-GCP guidelines.
  • Advanced proficiency with Microsoft Word, Excel, and PowerPoint.
  • Proficiency with eTMF systems.

Interested in this position?

Apply directly on the company website

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