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3 дня назад

Senior Clinical Research Associate (Oncology/Medical Devices)

Формат работы
remote (только USA)
Тип работы
fulltime
Грейд
senior
Английский
c1
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 (Oncology/Medical Devices): Managing 2–3 clinical trials and overseeing site start-up, monitoring, data quality, safety reporting, and closeout across oncology and medical device studies with an accent on on-site and remote monitoring, GCP compliance, and investigative site management. Focus on source data verification, resolving clinical data queries, managing trial materials and investigational products, and guiding CRA I staff.

Location: Remote within the West Coast, United States; willingness to travel to investigative sites as needed is required.

Company

hirify.global is a global, full-service contract research organization providing clinical research and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.

What you will do

  • Manage 2–3 clinical trials across oncology and medical device studies.
  • Support site selection, evaluation, initiation, periodic monitoring, and closeout activities.
  • Train site staff and serve as the primary contact for investigative sites.
  • Review case report forms, perform source data verification, resolve data queries, and support clinical data quality control.
  • Manage investigational products, trial materials, study files, safety reporting, and regulatory documentation.
  • Guide and supervise Clinical Research Associate I staff and report study activities and risks to department leadership.

Requirements

  • At least 10 years of clinical research experience, including on-site CRA monitoring experience.
  • Previous experience working for a CRO is required.
  • Experience with oncology, respiratory, complex clinical trials, and medical device research; gastrointestinal oncology and HIFU therapy experience is preferred.
  • University degree in a scientific, medical, or paramedical discipline, with nursing or a related background preferred.
  • Strong knowledge of clinical trial operations, GCP/ICH guidelines, and applicable regulatory requirements.
  • Fluent English, proficiency in Microsoft Office, and willingness to travel are required.

Culture & Benefits

  • Permanent, full-time employment.
  • Work with a diverse portfolio of emerging biotechnology and large pharmaceutical clients.
  • Continuous training and professional development support.
  • Work within a global organization with more than 4,000 professionals across over 20 countries.
  • Inclusive workplace focused on diversity, development, and clinical research that improves patient health and safety.

Hiring process

  • Submit a CV and receive an application acknowledgement.
  • Qualified candidates are invited to a phone interview as the first step.

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