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Clinical Project Specialist - Contract Position

2 hours, 19 minutes ago
Anywhere
Contract
Mid Level
Project Coordinator
Project and Program Management
Apply Now
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
51-250
Founded 1996
View All Jobs 2

Description

  • Develop, distribute, and maintain study plans and key clinical trial documents.
  • Coordinate feasibility activities, investigator selection, site activation, and site close-out.
  • Lead or mentor team members supporting site activation and closure activities.
  • Oversee TMF activities, quality control reviews, audits, and inspection readiness.
  • Schedule and facilitate team meetings, track action items, and communicate study updates.
  • Prepare status reports and distribute study information to sponsors, teams, and sites.
  • Manage vendors, deliverables, clinical supplies, resources, invoices, payments, and project tracking.
  • Ensure compliance with applicable regulations, ICH-GCP, FDA requirements, and company and sponsor SOPs.
  • Monitor project progress, resource needs, sponsor issues, team performance, billing trends, and deliverables.
  • Participate in regulatory inspections, mock inspections, audits, and related review activities.

Requirements

  • 2–4 years of progressive experience as a clinical research professional.
  • Ability to lead and coordinate study activities and team members.
  • Exceptional attention to detail and organizational skills.
  • Knowledge of FDA regulations and ICH-GCP guidelines.
  • Advanced proficiency in Microsoft Word, Excel, and PowerPoint.
  • Proficiency with electronic Trial Master File (eTMF) systems.
  • Experience developing or reviewing clinical trial documents, including protocols, investigator brochures, informed consent forms, CRFs, operations manuals, and site budgets.
  • Experience with site activation, TMF quality management, vendor management, or clinical project oversight is preferred.

Benefits

  • Collaborative work environment focused on clinical research and global health.
  • Opportunities to mentor team members and contribute to professional development.
  • Equal opportunity workplace committed to a discrimination- and harassment-free environment.

Interested in this position?

Apply directly on the company website

Apply Now

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