Thermo Fisher Scientific
Thermo Fisher Scientific
Thermo Fisher Scientific dezvoltă și furnizează tehnologii, produse de laborator și servicii farmaceutice care sprijină cercetarea științifică și asistența medicală. Activitatea sa acoperă cercetarea în domeniul științelor vieții, rezolvarea problemelor analitice, creșterea productivității laboratoarelor, diagnosticarea, precum și dezvoltarea și producția de terapii. Compania își deservește clienții printr-o echipă globală și un portofoliu de mărci care include Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon și PPD. Oportunitățile de carieră includ activitățile științifice, medicale, de producție, logistice și de servicii care susțin aceste oferte.

Senior Clinical Research Associate, Medical Device (Remote US)

Senior Clinical Research Associate supporting medical-device clinical trials for Thermo Fisher Scientific. The role covers site monitoring, compliance, data quality, documentation, and audit readiness across Central US locations.

Descriere

  • Coordinate clinical monitoring and clinical site management activities
  • Perform remote and on-site visits to evaluate protocol and regulatory compliance
  • Manage required trial documentation and sponsor procedures
  • Ensure studies follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs
  • Maintain audit readiness while building productive relationships with investigational sites
  • Monitor investigator sites through risk-based monitoring, root cause analysis, and corrective and preventive actions
  • Protect data accuracy through source data review, source data verification, and case report form review
  • Evaluate investigational product inventory and associated records
  • Record findings in reports and letters, escalating deficiencies through resolution
  • Stay in regular contact with investigational sites between monitoring visits
  • Track trial progress and provide status updates to the Clinical Team Manager
  • Maintain and quality-check clinical trial management systems
  • Participate in investigator meetings and help identify potential investigators
  • Activate clinical trial sites and support study closeout and material retrieval
  • Verify essential documents are complete and perform on-site file reviews
  • Support project publications, tools, trip report reviews, newsletters, and CRA team calls
  • Coordinate communication among investigational sites, the client company, and the project team
  • Address company, client, and regulatory requirements, including audits and inspections
  • Complete expense reports, timesheets, and other administrative duties
  • Support project activities and process improvement initiatives

Cerințe

  • Bachelor’s degree in a life sciences discipline, Registered Nursing certification, or an equivalent relevant academic or vocational qualification
  • At least two years of experience as a clinical research monitor
  • Valid driver’s license where applicable
  • Equivalent combinations of relevant education, training, and directly related experience may be considered
  • Demonstrated clinical monitoring capability
  • Knowledge of the relevant medical or therapeutic area and medical terminology
  • Working knowledge of ICH-GCP, applicable regulations, and procedural documents
  • Strong critical-thinking, root-cause analysis, and problem-solving abilities
  • Ability to apply risk-based monitoring concepts and processes
  • Clear spoken and written communication skills, including communication with medical personnel
  • Customer-focused approach with strong listening skills and attention to detail
  • Effective interpersonal, organizational, and time-management skills
  • Flexibility and adaptability in changing circumstances
  • Ability to work independently and collaboratively
  • Proficiency with Microsoft Office and capacity to learn required software
  • Strong English language and grammar skills
  • Effective presentation skills
  • Ability to follow sponsor, client, and site requirements, including potential vaccination-status or personal-information disclosures
  • Ability to use required personal protective equipment
  • Willingness to travel frequently, generally 60–80%, including possible extended overnight stays

Beneficii

  • Frequent travel, typically 60–80%, with higher travel levels for some individuals
  • Remote work arrangement combining remote and on-site monitoring
  • Standard Monday-to-Friday schedule

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