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3 дня назад

Senior Clinical Research Associate I (SCRA I)

Формат работы
remote (только Argentina)
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
Argentina
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 I (SCRA I) (Clinical Trials): Managing and monitoring investigator sites from initiation through database lock while supporting site activation, patient safety, and trial quality with an accent on ICH/GCP compliance, regulatory interactions, and complex site operations. Focus on resolving investigator-site issues, developing CAPAs, mentoring CRAs, overseeing investigational products and safety data, and collaborating across clinical research functions.

Location: Remote in Argentina; significant travel of 60–80% within the assigned area, with occasional international and weekend travel.

Company

hirify.global develops medicines and conducts global clinical research across multiple therapeutic areas.

What you will do

  • Independently manage and monitor investigator sites from initiation through database lock.
  • Support feasibility, site selection, Pre-Trial Assessments, activation checklists, informed consent finalization, and Site Initiation Visits.
  • Mentor and train Clinical Research Associates and serve as a subject matter expert for CRA-related processes.
  • Resolve complex site issues, implement CAPAs, manage quality-event remediation, and support regulatory inspections and sponsor interactions.
  • Monitor adverse events and serious adverse events, oversee investigational product handling, support database release, and conduct remote e-diary assessments.
  • Collaborate with Site Care Partners, Country SOMs, clinicians, recruitment specialists, and clinical data scientists on enrollment and protocol inquiries.

Requirements

  • Bachelor’s degree in Life Sciences or a professional degree in nursing, pharmacy, medicine, or an equivalent field.
  • At least 3 years of relevant clinical research site-monitoring experience; oncology experience is preferred.
  • Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA requirements, and local regulations.
  • Prior global clinical trial experience and fluency in English and the native language of Argentina.
  • Ability to work in a matrix environment, influence stakeholders, lead through others, interpret complex data, and support risk management.
  • Valid driver’s license and passport required; willingness to travel 60–80% is required.

Nice to have

  • At least 2 years of oncology experience.
  • Therapeutic experience in vaccines, internal medicine, or infectious diseases.

Culture & Benefits

  • Collaborative work across clinical operations, safety, data science, recruitment, and site-care functions.
  • Opportunities to mentor CRAs and contribute to regional working groups and process-improvement initiatives.
  • Exposure to global clinical trials and external investigator and regulatory stakeholders.
  • Remote work arrangement with substantial regional travel.

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