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6 дней назад

Clinical Research Associate II (Immunology)

84 500 - 162 000$
Формат работы
onsite
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
Clinical Research Associate II (Immunology) (Clinical Research/Immunology): Conducting site evaluation, training, monitoring, and closure activities for immunology clinical trials with an accent on GCP compliance, patient safety, data integrity, and site engagement. Focus on assessing and mitigating site risks, improving recruitment and retention, ensuring regulatory and inspection readiness, and mentoring less experienced CRAs.

Location: Detroit, Michigan, United States; the role involves onsite and offsite clinical site monitoring.

Salary: $84,500–$162,000 annual base pay.

Company

hirify.global develops innovative medicines and solutions across immunology, oncology, neuroscience, and aesthetics.

What you will do

  • Act as the primary point of contact for investigative sites and build effective partnerships with investigators and site staff.
  • Conduct site evaluation, training, routine monitoring, and site closure activities in accordance with protocols, monitoring plans, GCP, ICH guidelines, and SOPs.
  • Support patient recruitment and retention by applying therapeutic-area knowledge and understanding the patient journey.
  • Perform continuous risk assessment, identify site risk signals, and implement corrective and preventive action plans.
  • Ensure data quality, timely safety-event reporting, audit readiness, regulatory inspection readiness, and investigator payment compliance.
  • Mentor less experienced CRAs and contribute to clinical research task forces and initiatives.

Requirements

  • Health-related tertiary qualification in medicine, science, or nursing preferred.
  • At least 1 year of clinically related experience, including at least 6 months monitoring investigational drug or device trials.
  • Experience with risk-based monitoring, including onsite and offsite monitoring.
  • Knowledge of applicable regulatory and legal requirements, ICH/GCP guidelines, and clinical trial policies.
  • Strong planning, organization, communication, presentation, critical-thinking, and cross-functional collaboration skills.
  • Ability to work effectively in a fast-paced environment with competing projects and deadlines.

Culture & Benefits

  • Paid vacation, holidays, and sick leave.
  • Medical, dental, and vision insurance for eligible employees.
  • 401(k) plan for eligible employees.
  • Eligibility for short-term incentive programs.
  • Work focused on clinical research quality, patient safety, integrity, and innovation.

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