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    Lead Clinical Research Associate - Zug, Schweiz - PSI

    PSI
    PSI Zug, Schweiz

    vor 6 Tagen

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    Ganztags
    Beschreibung

    Job Description

  • Coordinates investigator/ site feasibility and identification process, as well as study startup.
  • Monitors project timelines and patient enrollment, implements respective corrective and preventive measures.
  • Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region.
  • Manages Monitors in the query resolution process, including Central Monitoring observations.
  • Coordinates safety information flow and protocol/process deviation reporting.
  • Performs clinical supplies management with vendors on a country and regional level.
  • Ensures study-specific and corporate tracking systems are updated in a timely manner.
  • Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager.
  • Coordinates planning of supervised monitoring visits and conducts the visits.
  • Manages the project team in site contracting and payments.
  • Leads project team calls on a country level as well as provides status updates and reports to Regional Lead/ Project Manager.
  • Ensures ongoing evaluation of data integrity and compliance at a country/regional level.
  • Conducts site audit preparation visits, may participate in site audits, and coordinates resolution of site audit findings on a country/regional level.
  • Oversees project team in CAPA development and implementation.
  • Coordinates project team in process deviations review, management and reporting.
  • Conducts initial training and authorization monitoring visits for Monitors and acts as a mentor for newly promoted Lead CRAs.
  • Provides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead.
  • Delivers trainings and presentations at Investigator Meetings.
  • Prepares, conducts and reports site selection, initiation, routine monitoring and closeout visits.
  • Ensures that subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level.
  • Ensures accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations.
  • Supervises source data verification and follows up on data queries at site level in the country/region; reviews and manages study risks on a site level.
  • Ensures proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on a country/region level.
  • Reviews essential study documents and supervises reconciliation of study Investigator Site File (ISF) / TMF at site level and country/region level.
  • Ensures data integrity and compliance at a site level.
  • Supervises Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/ Regional Lab/ Central Reviewer.
  • Conducts project-specific training of site Investigators.
  • Supports preparation of draft regulatory and ethics committee submission packages.

    • Qualifications

  • Relevant educational background, such as MD, MPharm, RN or College/University degree in Life Sciences or an equivalent combination of education, training and experience.
  • Minimum of 5 years' site monitoring experience with participation in global clinical projects as a Lead Monitor.
  • Experience with all types of monitoring visits in Phase II and/or III.
  • Strong experience in Oncology preferred.
  • Experience in CAR-T Therapy or other types of Cell Therapy, Gene Therapy, Radiation Therapy or Radiopharmaceuticals, or Nuclear Medicine is preferred.
  • Full working proficiency in English.
  • Proficiency in MS Office applications.
  • Ability to plan, multitask and work in a dynamic team environment.
  • Excellent Communication, collaboration, and problem-solving skills.
  • Ability to travel up to 65% (depending on project needs).
  • Valid driver's license (if applicable).

    • Additional Information

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