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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 - CRO Contract (Maryland Remote)

Contract Senior Clinical Research Associate responsible for monitoring clinical-trial sites and supporting study execution. Ensures compliance with GCP, FDA, ICH, protocol, and study-document requirements through site visits.

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

Descriere

  • Manage and monitor site activities independently across assigned clinical studies
  • Conduct site qualification, initiation, interim monitoring, and close-out visits
  • Evaluate sites and assess investigator and facility suitability
  • Lead study-startup activities, review protocols and regulatory matters, and train site staff
  • Maintain audit-ready Investigator Site Files and upload required documents to the Trial Master File on schedule
  • Coordinate directly with investigational sites on visit planning, query resolution, action items, and site management
  • Track accountability, stability, and storage conditions for clinical trial materials
  • Manage investigational product inventory and arrange the return or destruction of unused supplies
  • Act as the primary site contact while coordinating correspondence and timely clinical-data transmission
  • Complete close-out visits, investigational-product and site-file reconciliations, database-lock query resolution, and outstanding action follow-up
  • Complete required internal and study-specific training within established timelines
  • Handle pre- and post-visit follow-up, including confirmation letters, follow-up correspondence, and monitoring visit reports
  • Partner with the CRA Line Manager on CRA and junior-staff mentoring, training, and assessments when applicable
  • Follow required safety practices during travel and clinical research site visits

Cerințe

  • Bachelor’s degree or equivalent experience in life science or healthcare
  • At least five years of field experience in clinical research as a CRA
  • 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% of the time by domestic land and air transportation
  • Expertise in drug development, ICH guidelines, GCP, and clinical trial processes
  • Proficiency with electronic CRF platforms and related workflows
  • Strong interpersonal, organizational, and attention-to-detail skills
  • Ability to work independently, manage multiple priorities, and meet overlapping deadlines
  • Proficiency with computers, email, document, spreadsheet, and presentation software
  • Ability to submit invoices and expense reports according to Finance Department requirements
  • Ability to follow safety, environmental, infection-control, and personal-protective-equipment guidelines
  • Ability to lift or carry up to 10 pounds

Beneficii

  • The contractor is responsible for maintaining their own insurance
  • Home-office work environment available
  • Opportunities involving travel

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