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Senior Clinical Research Associate (Clinical Monitoring)

Формат работы
remote (только USA)
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 Monitoring): Overseeing clinical monitoring and site management for complex studies through feasibility, site visits, protocol compliance, source data verification, and audit-ready documentation with an accent on ICH-GCP, regulatory requirements, and stakeholder coordination. Focus on leading complex-site oversight, resolving data and protocol issues, developing study-specific monitoring documents, and training or coordinating CRAs.

Location: Remote within the United States; candidates must reside in a U.S. state where hirify.global is authorized to hire. Residents of California, Colorado, New York, Washington, New Jersey, Massachusetts, Illinois, Hawaii, and the District of Columbia are not eligible.

Company

hirify.global provides end-to-end clinical trial delivery, home health services, expanded access programs, and market access consultancy for biopharmaceutical sponsors.

What you will do

  • Oversee clinical monitoring and site management in compliance with GCP, global regulations, protocols, and company SOPs.
  • Contribute to study documents, lead site feasibility activities, and recommend sites for selection.
  • Plan and conduct site initiation, routine monitoring, and close-out visits, including on-site and remote activities.
  • Verify source data, CRFs, investigational product accountability, safety documentation, and protocol deviations while keeping site files audit-ready.
  • Manage data queries, corrective and preventive actions, action items, monitoring deliverables, and issue trends.
  • For assigned Lead CRA responsibilities, develop study-specific monitoring documents, finalize visit reports, train and coordinate CRAs, and act as the primary monitoring contact for project managers and sponsors.

Requirements

  • Bachelor’s degree in life sciences, nursing, or a related field preferred.
  • 5–7+ years of experience conducting on-site and remote monitoring visits, or equivalent clinical research experience; complex study experience is required.
  • Broad therapeutic exposure across multiple study types and indications, with strong scientific and medical terminology knowledge.
  • Advanced organizational, logistical, communication, and stakeholder-management skills, including the ability to manage multiple sites and protocols within timelines and budgets.
  • Experience training, coaching, and mentoring clinical research staff; proficiency with Microsoft Office and EDC systems.
  • Willingness to travel up to 80% and ability to remain stationary for extended periods, with reasonable accommodations considered where appropriate.

Culture & Benefits

  • Medical, dental, and vision insurance.
  • FSA, HSA, critical illness, hospital indemnity, accident, disability, and life insurance options.
  • 401(k) safe harbor plan with company match.
  • Paid vacation, holidays, sick time, volunteer time, and maternity and paternity leave.
  • Initiatives supporting wellness, professional growth, development, and team relationships.
  • Inclusive work environment focused on integrity, accountability, respect, and collaboration.

Hiring process

  • Submit an English resume through the hirify.global Careers Portal or LinkedIn Easy Apply.
  • An Upwage AI screener may be used as part of the application review; selected candidates proceed to interviews with the hirify.global team.

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