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1 день назад

Senior Clinical Research Associate

Формат работы
hybrid
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Senior Clinical Research Associate (Clinical Research): Conducting site management, remote data monitoring, and clinical study start-up activities with an accent on GCP compliance, source document verification, and regulatory documentation. Focus on mentoring CRAs, resolving data anomalies, contributing to monitoring and risk plans, and managing complex site activities with up to 25% travel.

Location: Research Triangle Park, North Carolina, United States; hybrid schedule with 3 days in office and 2 days remote. Up to 25% travel may be required for on-site visits.

Company

hirify.global develops longitudinal, multimodal clinical evidence for life sciences organizations through health system partnerships, data curation, and modern study design.

What you will do

  • Manage assigned clinical sites and conduct remote site selection and initiation visits.
  • Monitor studies in accordance with protocols, Good Clinical Practices, Standard Operating Procedures, and regulatory requirements.
  • Verify source documents, informed consent, site records, essential documents, queries, and data anomalies.
  • Document monitoring activities and support site start-up, regulatory document collection, and contracting workflows.
  • Review and contribute to Monitoring Plans, Trial Management Plans, Risk Plans, and related study procedures.
  • Mentor Clinical Research Associates and serve as a technical subject matter expert for management and other departments.

Requirements

  • Bachelor’s degree preferred, ideally in science or a related field, with 5+ years of CRA or advanced clinical data experience.
  • Substantial site management experience or equivalent clinical research and clinical studies experience.
  • Strong understanding of clinical research methodology and terminology.
  • Ability to independently manage multiple priorities, exercise judgment, and handle complex or unpredictable scenarios.
  • Excellent written and verbal communication, report-writing, Microsoft Office, and computer data acquisition skills.
  • Ability to work in a hybrid environment based in Research Triangle Park, North Carolina, with regular office attendance and travel of up to 25%.

Nice to have

  • Certified Clinical Research Associate certification.
  • Real-world evidence or Phase IV study experience.
  • Experience managing studies in REDCap Cloud.

Culture & Benefits

  • Hybrid work arrangement with regular onsite collaboration.
  • Comprehensive health, dental, and vision coverage.
  • 401(k) plan with company match.
  • Generous paid time off and paid parental leave.

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