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Parexel
Parexel
Sponsor pentru viza H1BAsistență medicalăConsultanțăLogistică
Parexel este o organizație globală de cercetare clinică ce deservește companii biofarmaceutice pe parcursul dezvoltării de medicamente noi. Activitatea sa acoperă studii clinice de fază I–IV, gestionarea portofoliilor și a studiilor, strategia de reglementare, accesul la piață și planificarea ciclului de viață. Cu peste 21.000 de profesioniști, Parexel îmbină expertiza clinică, de reglementare și terapeutică cu perspectivele pacienților și designuri inovatoare ale studiilor. Compania sprijină cercetarea în domenii precum oncologia, neuroștiințele și bolile rare, punând accent pe eficientizarea dezvoltării clinice și pe orientarea acesteia către pacienți.
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Clinical Research Associate II – Remote, Virginia

Parexel is hiring a Clinical Research Associate II to monitor investigator sites and support clinical trial quality, patient safety, recruitment, compliance, and close-out activities across the United States.

USStatele Unite ale AmericiiVAVirginiaRemoteNormă întreagăJuniorNivel mediuLimbă Obligatorie: englezăCercetare clinică
Google Cloud Platform

Descriere

  • Manage monitoring and close-out activities for assigned clinical trial investigator sites
  • Maintain patient safety and study quality in compliance with applicable laws, GCP, and sponsor standards
  • Oversee investigator site relationships and operations from activation through database lock
  • Act as the primary contact for assigned investigator sites
  • Coordinate information sharing among study teams, vendors, and investigator sites
  • Coach and train site personnel while providing protocol support
  • Assist with site activation, recruitment initiatives, and enrollment
  • Perform onsite and remote electronic monitoring during initiation, routine visits, and site closure
  • Track adverse events and serious adverse events in collaboration with the Drug Safety Unit
  • Prepare TMF documentation, site reports, follow-up letters, protocol deviations, recruitment updates, and study progress reports
  • Identify site issues, resolve them, and develop corrective and preventive actions
  • Resolve data queries and complete investigator site close-out activities
  • Oversee investigational product receipt, handling, accountability, storage, and destruction
  • Support database release and unblinded monitoring when appropriate
  • Maintain current knowledge of products, protocols, and relevant therapy areas
  • Support patient safety, eligibility assessments, and clinical guidance
  • Lead Quality Event remediation and audit CAPA activities when applicable

Cerințe

  • At least two years of relevant experience in clinical research site monitoring
  • Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA requirements, and applicable local regulations
  • Fluency in English and the native language or languages of the country of employment
  • Willingness and ability to travel 60–80%
  • Valid driver’s license and passport
  • Bachelor’s degree in life sciences or an equivalent professional life-sciences qualification, such as nursing, pharmacy, or a medical degree

Beneficii

  • Equal opportunity employment
  • Travel allowance is implied by the required travel; no explicit benefit is stated

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