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McKesson
McKesson
Sponsor pentru viza H1BAsistență medicalăConsultanțăLogistică

McKesson este o companie din domeniul sănătății care activează în distribuția de produse farmaceutice, furnituri medicale și servicii de sănătate. Activitatea sa ajută farmaciile, clinicile, sistemele de sănătate și pacienții să aibă acces la terapii esențiale, sprijinind în același timp operațiuni de sănătate mai eficiente și un răspuns rezilient la deficitul de medicamente.

Compania dezvoltă, de asemenea, software pentru gestionarea farmaciilor, servicii de consultanță și soluții tehnologice pentru cabinete specializate. McKesson colaborează cu organizații biotehnologice farmaceutice și sprijină cabinetele de oncologie și biofarmaceutice prin servicii axate pe accesul la medicamente, respectarea tratamentului, comercializare, informații bazate pe date și dovezi din practica reală.

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Research Regulatory Affairs Specialist – Tennessee

Support FDA, GCP, and IRB compliance for oncology clinical trials at Sarah Cannon Research Institute. Coordinate regulatory documentation and audit readiness with sponsors, research sites, and investigators in this remote Tennessee role.

USStatele Unite ale AmericiiTNTennesseeRemoteNormă întreagăJuniorNu este necesară o diplomăLimbă Obligatorie: englezăConformitate
Google Cloud Platform

Descriere

  • Plan regulatory compliance for industry sponsors and network research sites.
  • Partner with regulatory leaders and investigators to maintain compliance.
  • Prepare for audits while meeting demanding deadlines.
  • Set up and maintain electronic regulatory document systems.
  • Maintain FDA- and GCP-required records for sites, studies, sponsors, and networks.
  • Check regulatory documents against local procedures for format and content.
  • Keep essential compliance records current.
  • Revise or develop informed consent forms.
  • Manage protocol, investigator brochure, and consent form changes in line with IRB policy and HIPAA.
  • Coordinate time-sensitive communications with sponsors and other stakeholders.
  • Prepare and submit documentation to IRBs across multiple trials.
  • Process protocol deviations that meet IRB reporting criteria.
  • Send urgent safety notices to the IRB.
  • Carry out additional duties as assigned.

Cerințe

  • High school diploma or equivalent is required.
  • An associate degree or higher is preferred.
  • Relevant experience may substitute for education.
  • At least one year of regulatory affairs experience in clinical research, pharmaceuticals, or a site management organization is strongly preferred.
  • Knowledge of medical terminology is strongly preferred.
  • Knowledge of FDA and other regulatory processes is strongly preferred.
  • Ability to manage a full study workload with limited supervision.
  • Knowledge of IRB policies and HIPAA compliance.
  • Familiarity with FDA and GCP documentation requirements.
  • Ability to meet strict deadlines and prepare for audits.

Beneficii

  • A Total Rewards package with benefits supporting physical, mental, and financial well-being.
  • Competitive compensation.
  • Annual bonuses or long-term incentives may be available.
  • Equity may be part of compensation.
  • McKesson employee benefits.

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