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1 час назад

Senior Clinical Research Associate (Clinical Research)

74 500 - 197 500$
Формат работы
onsite
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): Monitoring and managing clinical trial sites in accordance with study protocols, Good Clinical Practice, applicable regulations, and sponsor requirements with an accent on site oversight, recruitment tracking, regulatory submissions, and study documentation. Focus on evaluating site quality, resolving data queries, maintaining TMF and ISF records, and coordinating study execution with project teams.

Location: Carlsbad, California, United States. Must reside in the same country where the job is located.

Annual base pay: $74,500–$197,500.

Company

IQVIA provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

  • Perform site selection, initiation, monitoring, and close-out visits in accordance with the study scope and Good Clinical Practice.
  • Manage site recruitment plans, enrollment tracking, regulatory submissions, approvals, and study progress.
  • Train assigned sites on protocols and study procedures and maintain regular communication to resolve issues.
  • Evaluate site quality, protocol compliance, and adherence to clinical research regulations, escalating issues when needed.
  • Maintain Trial Master File and Investigator Site File documentation and prepare monitoring reports, follow-up letters, and action plans.
  • Collaborate with study team members and support site financial management and invoice retrieval where applicable.

Requirements

  • Bachelor’s degree in a scientific or healthcare discipline preferred; equivalent education, training, and experience may be accepted.
  • At least 3 years of on-site monitoring experience.
  • Knowledge of clinical research regulatory requirements, including Good Clinical Practice and International Conference on Harmonization guidelines.
  • Therapeutic and protocol knowledge acquired through company training.
  • Proficiency with Microsoft Word, Excel, PowerPoint, laptops, and applicable mobile devices.
  • Good command of English, strong communication, organization, problem-solving, time management, and financial management skills.

Culture & Benefits

  • Full-time employment.
  • Potential incentive plans, bonuses, and additional compensation depending on the position.
  • Health, welfare, and other benefits may be provided.
  • Equal opportunity employment commitment.

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