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11 дней назад

CRA II, Onc/Neuro/Rare/Derm (West Coast, Midwest, Northeast)

80 000$
Формат работы
remote (только USA)
Тип работы
fulltime
Грейд
middle
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
CRA II, Onc/Neuro/Rare/Derm (West Coast, Midwest, Northeast) (Clinical Monitoring): Conducting qualification, initiation, interim, and close-out monitoring visits for clinical trials with an accent on data integrity, patient safety, regulatory compliance, and site communication. Focus on resolving clinical data queries, maintaining TMF/eTMF records, assessing recruitment feasibility, and supporting oncology, rare disease, neurology, or dermatology studies with 70–85% travel.

Location: Remote within the United States; candidates must be located in the West Coast, Midwest, or Northeast regions. The role requires 70–85% travel and includes remote and onsite monitoring visits.

Annualized minimum base pay: $80,000 USD. Actual salary depends on qualifications, skills, competencies, and proficiency.

Company

hirify.global supports biotech, medtech, and specialty pharmaceutical companies in developing medicines, medical devices, and diagnostics.

What you will do

  • Conduct qualification, initiation, interim, and close-out monitoring visits according to clinical monitoring plans.
  • Ensure data integrity, patient safety, regulatory compliance, and timely completion of monitoring reports.
  • Manage site queries and verify the validity, correctness, and completeness of clinical data.
  • Maintain TMF/eTMF records, review site documentation, and oversee investigational product accountability logs.
  • Communicate with study sites, investigators, project teams, and management, including participation in investigator meetings and study training.
  • Support recruitment feasibility, reduce project backlogs, track site metrics, and serve as a resource for other CRAs.

Requirements

  • Undergraduate degree or equivalent experience in a clinical, science, or health-related field, or a licensed healthcare professional qualification.
  • At least 2 years of clinical-trial experience and proven CRA experience, including completion of a CRA training program.
  • Knowledge of ICH/GCP, FDA, EU and local regulations, ISO 14155, drug and device development, and clinical monitoring procedures.
  • Experience in oncology, rare disease, neurology, or dermatology.
  • Strong organization, judgment, communication, collaboration, mentoring, and problem-solving skills.
  • Valid driver’s license and passport as required; ability to travel 70–85% and lift up to 25 lbs.

Culture & Benefits

  • Remote work with flexibility and work-life balance.
  • Opportunities for professional growth, skills development, and expanded responsibilities.
  • Health insurance, retirement plans, and paid time off may be included in the benefits package.
  • Equal-opportunity employment compliant with federal guidelines.

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