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Senior Clinical Research Associate

11 hours, 14 minutes ago
Not Available
Full-time
Senior
Operations Specialist
Operations
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 5

Description

  • Conduct qualification, initiation, interim, and close-out site visits for clinical studies.
  • Train and manage site personnel on therapeutic areas, protocols, source documentation, and case report forms.
  • Track investigational supplies, product dispensing, inventory, and reconciliation.
  • Monitor laboratory sample storage and shipment.
  • Review and report enrollment, site status, monitoring visits, protocol deviations, serious adverse events, and laboratory abnormalities.
  • Verify source data and case report forms for accuracy, completeness, and integrity, and resolve data issues.
  • Review data queries and listings and work with study centers to resolve discrepancies.
  • Review regulatory documentation and support study centers with regulatory issues.
  • Maintain complete and accurate study files and ensure required documentation is present.
  • Provide support and solutions to project team members, including CRA I and CRA II staff.

Requirements

  • RN, bachelor’s or advanced degree in biological sciences or a related field, or an equivalent combination of education, training, and relevant experience.
  • Previous CRA experience demonstrating career growth in the CRA role.
  • Extensive knowledge of FDA regulations and their practical implementation.
  • Familiarity with the medical and pharmaceutical industries, terminology, and practices.
  • Strong attention to detail, organizational, interpersonal, communication, and problem-solving skills.
  • Ability to adapt to changing priorities and efficiently prioritize multiple tasks.
  • Ability to travel by air or car, including on short notice; travel may reach 65%.
  • Proficiency in Microsoft Word, Excel, and PowerPoint.

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 opportunities.
  • Collaborative and supportive work environment.

Interested in this position?

Apply directly on the company website

Apply Now

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