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8 часов назад

Senior Clinical Research Associate, Field Monitor

128 000 - 140 000$
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, Field Monitor (Clinical Trials): Conducting remote and on-site monitoring for clinical trials with an accent on patient safety, data reliability, regulatory compliance, and risk-based quality management. Focus on protocol interpretation, source data verification, site risk mitigation, complex data-query resolution, and mentoring clinical research associates.

Location: Remote; flexible hours required to accommodate various time zones and site locations. Travel of up to 50–75% is required, including overnight travel.

Annual base pay: $128,000–$136,000 for the national market and $133,000–$140,000 for premium markets including Los Angeles, San Diego, San Francisco, New York City, Chicago, and Boston. The position is also eligible for a discretionary bonus and equity award.

Company

hirify.global is a commercial-stage biotechnology company developing immunotherapies, cell therapies, cancer vaccines, and treatments for infectious diseases.

What you will do

  • Execute site selection, site initiation, routine monitoring, and close-out visits for assigned clinical trial sites.
  • Conduct remote, risk-based, and on-site monitoring, including source data verification and investigational product accountability reconciliation.
  • Interpret study protocols and provide sites with guidance on eligibility, safety reporting, scientific rationale, and protocol requirements.
  • Identify and mitigate site risks using Risk-Based Quality Management principles, review clinical data, resolve complex queries, and address protocol deviations.
  • Support study start-up and conduct through eTMF maintenance, training materials, recruitment and retention strategies, specimen logistics, and investigational product supply coordination.
  • Prepare for audits and inspections, support CAPA development, and mentor newly hired field and in-house CRAs.

Requirements

  • Bachelor’s degree in clinical research, science, or a health-related discipline, or Registered Nurse status with at least 5 years of on-site monitoring experience.
  • At least 6 years of clinical trial experience in a pharmaceutical, biotechnology, CRO, or healthcare setting.
  • At least 4 years of independent on-site and remote monitoring experience.
  • Current valid driver’s license and successful motor vehicle record checks upon hire and annually thereafter.
  • Advanced knowledge of drug development, medical terminology, ICH-GCP E6(R3), and the Code of Federal Regulations.
  • High proficiency with EDC, eTMF, CTMS, Microsoft Office, and Adobe, plus strong written, oral, and presentation skills in English.

Culture & Benefits

  • Collaborative environment with opportunities to work across different areas of the company.
  • Professional development opportunities within a growing publicly traded biopharmaceutical company.
  • Medical, dental, and vision plan options, health and financial wellness programs, and an employee assistance program.
  • Life, disability, flexible spending, 401(k) with company match, and 529 education savings benefits.
  • Paid time off, including holidays, with unlimited PTO for exempt employees.
  • Remote work arrangement with flexible hours and eligibility for additional rewards, discounts, legal services, identity theft protection, and pet insurance.

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