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12 часов назад

Clinical Trial Associate / Senior Clinical Trial Associate (Biotech)

80 000 - 110 000$
Формат работы
remote (только USA)/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
Clinical Trial Associate / Senior Clinical Trial Associate (Clinical Operations): Supporting clinical trial operations, site start-up, study tracking, and Trial Master File maintenance with an accent on regulatory documentation, site activation, vendor coordination, and clinical systems. Focus on managing study portals and metrics, driving enrollment timelines, maintaining GCP-compliant records, and coordinating deliverables across sites, CROs, vendors, and internal teams.

Location: San Carlos, California; remote candidates may be considered. Up to 10% travel may be required.

Salary: $80,000–$110,000 per year, depending on work location, skills, experience, education, and training.

Company

hirify.global is a privately held, clinical-stage biopharmaceutical company developing antibody therapeutics for cancer, autoimmune disorders, neurology, and other serious diseases.

What you will do

  • Provide administrative and operational support to the Clinical Operations team under Clinical Trial Manager and Lead Clinical Trial Associate supervision.
  • Create and maintain study trackers covering start-up requirements, regulatory documents, IRB submissions, site information, enrollment, visits, EDC metrics, laboratory supplies, and study documentation.
  • Support site start-up from confidentiality agreements and feasibility questionnaires through site activation, working with site staff and CRAs to advance enrollment goals and timelines.
  • Maintain study document portals, site access, study tools, and the Trial Master File.
  • Coordinate with clinical trial sites, CROs, vendors, and internal and external project teams; track deliverables and escalate issues as needed.
  • Contribute to vendor management, site relationships, process improvements, and study team reporting.

Requirements

  • Bachelor's degree preferred; high school diploma or equivalent required.
  • At least 1–2 years of experience in clinical research, preferably in oncology.
  • Experience with EDC, IRT, TMF, and CTMS systems.
  • Knowledge of FDA and/or EMEA regulations, ICH Guidelines, GCPs, and the drug development process.
  • Proficiency in Microsoft Office and Adobe Acrobat, with excellent verbal, written, and interpersonal communication skills.
  • Strong organization, time management, problem-solving, independent working, collaboration, and prioritization skills.

Culture & Benefits

  • Competitive cash compensation, equity incentive awards, and employer-sponsored benefits.
  • Work effectively with remote collaborators and cross-functional teams.
  • Patient-centric approach to clinical research.
  • Equal opportunity employment practices.

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