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Clinical Research Staffing

  • Clinical Research Staffing

    With new opportunities being gotten each day for clinical research employments, our expert group of enrollment specialists have immense industry knowledge and involvement in this part. We just work with exceedingly legitimate associations and comprehend our applicants and clients needs profoundly to guarantee a decent match on the two sides.


  • Clinical Trials Management

    ● Clinical Study Managers

    ● Clinical Research Associates

    ● Clinical Research Coordinators

    ● Safety Review Nurses

  • Data Management

    ● Clinical Data Managers

    ● Clinical Data Analysts

    ● Clinical Data Support Specialists

    ● SAS Programmers

    ● Biostatisticians

    ● Bioinformatics
     

  • Clinical Application Development

    ● ​SAS Developers

    ● Documentum Developers

    ● Oracle Clinical Developers

    ● Project Managers & Analysts

  • Regulatory Affairs and Quality Assurance Validation

    ● Consultation

    ● Strategy & Program Development

    ● Assessments

    ● Master Planning

    ● Protocol Development & Execution

    ● Software/21 CFR Part 11

    ● Equipment

    ● Program Outsourcing


  • Compliance & Quality Systems

    ● Consultation

    ● Regulatory Gap Analysis

    ● Program Development

    ● GMP/QSR

    ● FDA Readiness Audit

    ● Planning, Implementation & Training


  • Clinical Study Compliance

    ● GLP Assessments

    ● GCP Compliance Assessments

    ● Clinical Investigator

    ● Sponsor

    ● Monitor

    ● Central Study File

    ● Database and Data Mgmt

    ● Institutional Review Board

  • Capabilities

     ● Validation Projects or Staffing

    ● Clinical Systems Risk Assessment

    ● Validation Project Management

    ● 21 CFR Part 11

    ● Test Script Creation & Execution

    ● Quality & System Audits

    ● Training & Education Programs

    ● HIPAA

    ● Sarbanes-Oxley

  • Drug Safety and Pharmacovigilance

    ● Individual Case Safety Reports (ICSRs)

    ● Periodic Safety Update Reports (PSURs)

    ● Annual Safety Reports (ASRs)

    ● Summary Bridging Reports (SBRs)

    ● Scientific Literature Surveillance

    ● SAE Management and Reconciliation

    ● Case Narrative Writing

    ● Medical Coding

    ● Safety Signal Detection

    ● Epidemiology Consultation

    ● Risk Management

    ● Regulatory Consultation