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Advarra
Advarra
501 – 1.000 Angajați
ConsultanțăLogisticăMarketing
Advarra reunește tehnologii și servicii de cercetare clinică pentru întregul ciclu de viață al studiilor clinice. Activitatea sa cuprinde evaluări de etică și conformitate, inclusiv servicii pentru comitete de etică instituționale (IRB), comitete instituționale de biosecuritate (IBC) și comitete de monitorizare a datelor, precum și sprijin pentru centrele de cercetare, recrutarea personalului de cercetare și instrumente cloud pentru gestionarea aspectelor de reglementare, a consimțământului, a colectării datelor, a studiilor și a proiectării acestora. Compania oferă și Braid, un motor de inteligență operațională bazat pe inteligență artificială, conceput pentru a sprijini pregătirea studiilor, recrutarea participanților și activitățile zilnice. Advarra deservește sponsorii, organizațiile de cercetare contractuale, centrele de cercetare și instituțiile, cu echipe active în protecția participanților, conformitatea cu reglementările și operațiunile de cercetare clinică.
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Locurile de muncă ale companiei

Scientific Institutional Review Board Member

Serve on Advarra’s scientific IRB, reviewing clinical research submissions and helping ensure regulatory compliance. Contribute to board meetings and support sponsors, investigators, and research teams on clinical and regulatory matters.

USStatele Unite ale Americii
58.495 $ – 96.517 $ / an
RemoteNormă întreagăNivel mediuSeniorLimbă Obligatorie: englezăManager de afiliereMarketing afiliat

Descriere

  • Maintain the Review Board’s knowledge of and compliance with regulatory requirements, Advarra’s Board Standard Operating Procedures, and organizational policies.
  • Support timely completion of core Institutional Review Board reviews while upholding professionalism and regulatory compliance.
  • Use scientific knowledge and regulatory expertise to answer questions and address day-to-day challenges.
  • Help triage submissions and review those assigned to expedited or full board review.
  • Attend full board meetings and present protocol-related issues when needed.
  • Flag cases needing guidance, inconsistencies in Board reviews, and related issues to senior regulatory staff.
  • Advise sponsors, investigators, and contract research organizations on clinical and regulatory affairs.
  • Partner with Regulatory Leadership to assess membership needs and support Board member development.
  • Promote accountability through team building, training, mentoring, collaboration, motivation, and mutual respect.

Cerințe

  • Bachelor’s degree.
  • Preferred: at least one year of IRB or clinical research industry experience, or at least three years of healthcare experience within the past six years.
  • A master’s or other graduate degree focused on a scientific discipline is preferred.
  • Strong understanding of biological and/or pharmacological sciences through education or experience.
  • Superior knowledge of regulatory requirements, Advarra’s Board Standard Operating Procedures, and organizational policies and procedures.
  • Ability to learn and understand basic instructions.
  • Ability to stay focused and attentive to tasks and responsibilities.
  • Verbal communication skills, including listening, understanding, responding, and speaking.
  • Ability to regularly carry, lift, and lower objects weighing up to 10 pounds.
  • Ability to sit or stand for extended periods at a stationary workstation.

Beneficii

  • A variable bonus may be available in addition to base salary.
  • Health coverage.
  • Paid holidays.
  • Equal opportunity workplace.
  • Inclusive and collaborative work environment.

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