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Lead Clinical Research Associate

3 weeks, 3 days ago
Anywhere
Full-time
Lead
Project Manager
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 6

Description

  • Provide study oversight and serve as the primary liaison among CRAs, CTAs, study sites, investigators, clients, internal teams, and external vendors.
  • Ensure CRA monitoring activities comply with SOPs, regulations, Good Clinical Practice, key performance indicators, and study requirements.
  • Develop and manage clinical monitoring plans, guidelines, timelines, and monitoring intervals.
  • Review CTMS data, reports, listings, site documentation, and discrepancies, and coordinate resolution with CRAs and site staff.
  • Create annotated visit report templates and other site management and monitoring documents.
  • Train and support CRAs, CTAs, and external CRO personnel, ensuring study-specific training is completed and documented.
  • Guide monitoring, co-monitoring, training, and audit visits; review site visit reports and monitoring letters.
  • Oversee TMF/eTMF filing and quality control.
  • Track serious adverse events, protocol deviations, enrollment, informed consent forms, study contacts, investigational supplies, and investigational product.
  • Perform qualification, initiation, interim, and closeout visits and prepare visit reports as needed.

Requirements

  • RN, bachelor’s degree, or advanced degree in biological sciences or a related field, or an equivalent combination of education, training, and experience.
  • Previous CRA experience preferred.
  • Extensive knowledge of FDA regulations and their practical implementation.
  • Familiarity with the medical and pharmaceutical industries, terminology, and practices.
  • Strong communication, organization, prioritization, presentation, discretion, and accuracy skills.
  • Solutions-oriented approach to problem solving.
  • Willingness to travel and conduct remote and on-site monitoring as needed.
  • Proficiency with Microsoft Word, Excel, and PowerPoint.

Benefits

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

Interested in this position?

Apply directly on the company website

Apply Now

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