Clinical Project Specialist

8 hours, 24 minutes ago
Full-time
Junior
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
51-250
Founded 1996

Description

  • Document, distribute, and maintain study plans throughout the project lifecycle.
  • Develop and review essential study documents, including protocols, investigator brochures, informed consent forms, CRFs, operations manuals, study aids, and site budgets.
  • Coordinate feasibility activities, investigator screening, site selection, activation, and close-out.
  • Manage essential document approval, TMF quality control, inspection readiness, audits, and regulatory inspection support.
  • Schedule and facilitate team meetings; prepare agendas, minutes, communications, and action-item tracking.
  • Provide project status updates and maintain communication with sponsors, project leadership, and CRA/CTA teams.
  • Support vendor selection and management, including CROs, data management groups, packaging providers, and central laboratories.
  • Coordinate CTA resource planning, deliverable tracking, clinical supplies, data collection, billing, and site invoices.
  • Mentor CTA team members and provide feedback on goals, performance, and deliverables.
  • Ensure compliance with FDA regulations, ICH-GCP, local regulations, and company and sponsor SOPs.

Requirements

  • 2–4 years of progressive experience as a clinical research professional.
  • Ability to lead, coordinate, and oversee project activities and team members.
  • Exceptional attention to detail and strong 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.

Benefits

  • Medical, dental, and vision insurance for employees and families.
  • Flexible paid time off.
  • 401(k) plan with company match.
  • Professional growth, skills development, and career advancement support.
  • Collaborative and supportive work environment.

Interested in this position?

Apply directly on the company website

Apply Now

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