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Clinical Project Specialist - Contract Position

10 hours, 38 minutes ago
Anywhere
Contract
Junior
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 10

Description

  • Develop, distribute, and maintain study plans throughout the project lifecycle.
  • Develop and review essential study documents, including protocols, investigator brochures, ICFs, CRFs, operations manuals, study aids, and site budgets.
  • Coordinate feasibility activities and review site capability information.
  • Manage site activation and close-out activities, including task execution and team mentoring.
  • Oversee TMF activities, quality control reviews, audits, and inspection readiness.
  • Schedule and support team meetings, track action items, and prepare status reports and study communications.
  • Manage vendors and monitor deliverables from CROs, data management groups, laboratories, and packaging providers.
  • Coordinate CTA resource planning, deliverable tracking, clinical supplies, data collection, billing codes, site invoices, and payments.
  • Ensure compliance with applicable regulations, ICH-GCP, FDA requirements, and company and sponsor SOPs.
  • Mentor CTA team members and communicate project progress, resource needs, sponsor issues, and performance concerns to project leadership.

Requirements

  • 2–4 years of progressive clinical research experience.
  • 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 with TMF quality control, audits, and inspection readiness.
  • Experience with site activation, close-out, vendor management, and clinical trial documentation.
  • Ability to collaborate effectively with sponsors, sites, project leadership, and cross-functional teams.

Benefits

  • Collaborative work environment focused on advancing global health.
  • Opportunities to take ownership of clinical trial activities and work directly with sponsors.
  • Mentoring and professional development opportunities through CTA team leadership.
  • Equal opportunity workplace committed to nondiscrimination and harassment-free employment.

Interested in this position?

Apply directly on the company website

Apply Now

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