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Lead Clinical Research Associate - Contract Position

8 hours, 34 minutes ago
Anywhere
Contract
Lead
Project Manager
Project and Program Management
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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

  • Provide study oversight and serve as the primary liaison among CRAs, CTAs, investigators, sites, clients, and external vendors.
  • Ensure monitoring activities comply with SOPs, regulations, Good Clinical Practice, key performance indicators, and study requirements.
  • Develop and manage clinical monitoring plans, guidelines, timelines, reports, and monitoring intervals.
  • Review clinical data, CTMS information, and site documentation; coordinate resolution of data discrepancies.
  • Create annotated visit report templates and site management and monitoring strategies.
  • Support team training and development while ensuring study-specific training is completed and documented.
  • Guide CRAs, CTAs, and external CROs during monitoring, co-monitoring, training, and audit visits; review visit reports and monitoring letters.
  • Oversee the TMF/eTMF, including 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 close-out visits and prepare required 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 industry, terminology, and practices.
  • Strong communication, organization, prioritization, presentation, discretion, and accuracy skills.
  • Solutions-oriented approach to problem solving.
  • Willingness to travel and perform remote and on-site monitoring as needed.
  • Proficiency with Microsoft Word, Excel, and PowerPoint.

Benefits

  • Collaborative workplace focused on clinical research and global health impact.
  • Equal opportunity employer committed to a workplace free from discrimination and harassment.

Interested in this position?

Apply directly on the company website

Apply Now

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