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Evolution Research Group
Evolution Research Group
501 – 1.000 Angajați
Asistență medicalăBiotehnologieConsultanță
Evolution Research Group este o organizație de cercetare clinică din domeniul sănătății și biotehnologiei, care sprijină dezvoltarea unor terapii noi prin studii clinice inovatoare. Activitatea sa acoperă psihiatria, neurologia, gestionarea durerii, dependențele și afecțiunile cronice, cu accent pe cercetarea în fazele timpurii și recrutarea eficientă a participanților. Organizația colaborează cu furnizori de servicii medicale și grupuri de sprijin și advocacy pentru a extinde accesul la studii și pentru a contribui la asigurarea faptului că cercetarea clinică reflectă nevoile pacienților pe care îi deservește.
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Senior Clinical Research Associate (CRA) – Maryland Remote Contract

Contract Senior Clinical Research Associate overseeing clinical trial sites for Lotus Clinical Research. The role covers GCP compliance, essential documentation, investigational product accountability, and study close-out.

USStatele Unite ale AmericiiMDMaryland
0 $ – 110 $ / oră
RemoteContractSeniorLimbă Obligatorie: englezăCercetare clinică
Google Cloud Platform

Descriere

  • Independently oversee and monitor site activities across assigned clinical studies
  • Conduct site qualification, initiation, interim monitoring, and close-out visits
  • Maintain compliance with study protocols, Lotus or Sponsor SOPs, FDA regulations, and ICH-GCP requirements
  • Evaluate clinical sites and assess investigator and site capabilities
  • Lead study initiation tasks, review protocols and regulatory matters, and train site personnel
  • Keep Investigator Site Files audit-ready and upload required documents to the Trial Master File
  • Coordinate with investigational sites on visit scheduling, query resolution, action items, and site management
  • Track clinical trial material accountability, stability, and storage conditions, and complete investigational product inventories
  • Manage site correspondence and support timely clinical data transmission
  • Complete close-out visits, investigational product reconciliation and disposition, study file reconciliation, database-lock query resolution, and remaining action items
  • Finish internal and study-specific training within required deadlines
  • Handle pre- and post-visit follow-up, including confirmation letters, follow-up correspondence, and monitoring reports
  • Partner with the CRA Line Manager on CRA and junior staff mentoring, training, and assessment when applicable

Cerințe

  • Bachelor’s degree or equivalent experience in life sciences or healthcare
  • At least five years of field experience as a Clinical Research Associate
  • Demonstrated mastery of CRA II responsibilities
  • Valid driver’s license
  • Legal authorization to work in the United States as an independent contractor through an LLC, INC., or agency
  • Ability and willingness to travel up to 100% domestically by land and air
  • Expertise in drug development, ICH guidelines, GCP, and clinical trial operations
  • Proficiency with electronic case report form platforms and related processes
  • Strong interpersonal, organizational, and multitasking abilities
  • Exceptional attention to detail and professional judgment
  • Ability to uphold ICH GCP requirements and select appropriate responses to complex issues
  • Capacity to manage multiple deadlines while working independently
  • Proficiency with computers, email, document, spreadsheet, and presentation software
  • Ability to submit invoices and expense reports on time in accordance with Finance Department requirements
  • Ability to meet physical requirements, including occasional lifting or carrying of up to 10 pounds
  • Willingness to follow safety, environmental, infection-control, and protective-equipment requirements while traveling to or visiting clinical research sites

Beneficii

  • The contractor is responsible for obtaining and maintaining personal insurance
  • Option to work from a home office
  • Opportunity to mentor, train, and assess CRAs and junior staff

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