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Lead Clinical Research Associate

1 month, 1 week 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 2

Description

  • Provide study oversight as the primary liaison between CRAs, internal staff, study site staff, client personnel, and external vendors throughout all study stages.
  • Lead, direct, and support the CRA team and assigned CTAs to ensure timely and accurate initiation, enrollment, conduct, and completion of studies.
  • Ensure clinical monitoring activities are performed in accordance with SOPs, regulations, Good Clinical Practice (GCP), key performance indicators, and study-specific requirements.
  • Develop, review, and manage clinical plans and guidelines, including the clinical monitoring plan and study timelines, and ensure compliance with monitoring intervals.
  • Review data reports and CTMS listings, disseminate reports to study CRAs, and work with CRAs and site staff to resolve data discrepancies.
  • Create annotated visit report templates and other site management/monitoring documents and strategies.
  • Guide and support CRAs, CTAs, and external CROs on monitoring, co-monitoring, training, and audit visits, and review site visit reports and monitoring letters for compliance.
  • Manage oversight of the Trial Master File (TMF/eTMF), assist with filing and quality control, and track SAEs, protocol deviations, enrollment, ICFs, investigational supplies, and investigational product.

Requirements

  • RN, Bachelor’s, or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education, and training.
  • Previous CRA experience preferred.
  • Experience leading, mentoring, or providing direction to CRA/CTA teams or other clinical monitoring staff (preferred).
  • Extensive knowledge of FDA regulations and practical implementation of regulatory requirements and GCP.
  • Familiarity with the medical and pharmaceutical industry, terminology, and practices.
  • Willingness to travel and perform remote and on-site monitoring as needed.
  • Proficiency in Microsoft Word, Excel, and PowerPoint; experience with CTMS and eTMF is expected based on role duties.
  • Strong professional skills including communication, organization, prioritization, presentation, discretion, accuracy, and a solutions-oriented approach to problem solving.

Benefits

  • Competitive salary range: $135,000 - $159,000 per year (actual compensation may vary by experience, location, and other factors).
  • Home-based/remote work arrangement with emphasis on work–life balance.
  • Contract/remote clinical operations role offering flexibility in location and schedule.
  • Collaborative company culture focused on meaningful clinical research and professional community.
  • Opportunity to contribute to clinical studies that support development of treatments and improved patient care.

Interested in this position?

Apply directly on the company website

Apply Now

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