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Lead Clinical Research Associate - Pipelining for Future Jobs

1 hour, 35 minutes 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 2

Description

  • Provide study oversight and serve as the primary liaison among CRAs, internal staff, site personnel, client personnel, and external vendors throughout all stages of the study.
  • Lead and support CRA and CTA teams to ensure accurate and timely study initiation, enrollment, conduct, and closeout.
  • Ensure clinical monitoring activities comply with SOPs, regulations, good clinical practices, key performance indicators, and study-specific requirements.
  • Develop, review, and manage clinical plans, monitoring plans, and study timelines.
  • Review data reports and CTMS outputs, distribute relevant listings and reports to CRAs, and help resolve data discrepancies with site staff.
  • Create annotated visit report templates and other site management and monitoring documents and strategies.
  • Support team training and development, document training completion, and ensure study-specific training requirements are met.
  • Guide CRAs, CTAs, and external CROs on monitoring, co-monitoring, training, audit visits, and review site visit reports and monitoring letters.
  • Manage oversight of the TMF/eTMF and assist with filing and quality control.
  • Track study metrics and materials, including serious adverse events, protocol deviations, enrollment, ICFs, 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 relevant experience, education, and training.
  • Previous CRA experience preferred.
  • Strong communication, organization, prioritization, presentation, discretion, and accuracy skills.
  • Solutions-oriented approach to problem solving.
  • Familiarity with the medical and pharmaceutical industry, including related terminology and practices.
  • Extensive knowledge of FDA regulations and their practical implementation.
  • Willingness to travel and perform both remote and on-site monitoring as needed.
  • Proficiency in Microsoft Word, Excel, and PowerPoint.

Benefits

  • Full medical, dental, and vision insurance options for employees and their families.
  • Flexible PTO to support personal and professional needs.
  • 401(k) plan with company match.
  • Career growth support and opportunities to expand skills or advance professionally.
  • Remote work arrangement for a home-based role.
  • Salary range of $135,000 to $159,000 per year.

Interested in this position?

Apply directly on the company website

Apply Now

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