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2 дня назад

Senior/Clinical Research Associate (Oncology)

Формат работы
remote (только Australia)
Тип работы
fulltime
Грейд
senior
Английский
c1
Страна
Australia
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/Oncology): Supporting clinical study sites and project teams in oncology and rare disease research with an accent on site management, patient safety, data integrity, and regulatory compliance. Focus on independently conducting monitoring visits, resolving site risks and data discrepancies, maintaining essential trial documentation, and supporting investigational product oversight.

Location: Remote, Australia. Travel required for approximately 60–70% of the role.

Company

hirify.global is a contract research organization integrating clinical trial execution with scientific, laboratory, and data science expertise, with a focus on oncology and rare disease.

What you will do

  • Manage clinical study sites and act as a point of contact for investigators, site staff, and clinical project teams.
  • Conduct qualification, initiation, routine monitoring, and close-out visits in accordance with protocols, ICH-GCP, local regulations, and SOPs.
  • Monitor patient safety, informed consent, protocol compliance, data quality, serious adverse events, and investigational product accountability.
  • Maintain trial management systems, monitoring reports, communication logs, Investigator Site Files, and other required documentation.
  • Identify, escalate, and resolve site risks, protocol deviations, data discrepancies, and action items with minimal support.
  • Support site start-up, investigator recruitment, regulatory submissions, patient recruitment, audits, investigator meetings, and clinical training.

Requirements

  • Bachelor’s degree or international equivalent, ideally in a business, scientific, or healthcare discipline, or an equivalent combination of education and experience.
  • At least 3 years of on-site monitoring experience.
  • Fluent English communication, both written and verbal, is required.
  • Working knowledge of the drug development process, ICH-GCP, regulatory guidance, and clinical research procedures.
  • Strong attention to detail, organization, communication, teamwork, independent planning, and problem-solving skills.
  • Proficiency in Microsoft Office, including Outlook, Word, Excel, and PowerPoint.

Nice to have

  • At least 2 years of oncology and Phase I experience.
  • Additional solid experience in clinical research or a related field.
  • Experience working efficiently in a remote environment.

Culture & Benefits

  • Remote work arrangement in Australia with project-related travel.
  • Opportunity to contribute to clinical research for cancer therapies and rare diseases.
  • Work in a multidisciplinary environment combining clinical operations, scientific expertise, laboratory capabilities, and data sciences.
  • Employees are encouraged to contribute ideas and support positive organizational change.

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