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Clinical Research Associate Lead

vor 1 Monat

Zug, Zug, Schweiz PSI Vollzeit

Job Summary

The Lead Clinical Research Associate will be responsible for coordinating investigator/site feasibility and identification, as well as study startup. This role will also involve monitoring project timelines and patient enrollment, implementing corrective and preventive measures as needed.

Key Responsibilities

  • Coordinate investigator/site feasibility and identification process, as well as study startup.
  • Monitor project timelines and patient enrollment, implement corrective and preventive measures as needed.
  • Review monitoring visit reports for all visit types and ensure reporting compliance of monitors in the region.
  • Manage monitors in the query resolution process, including central monitoring observations.
  • Coordinate safety information flow and protocol/process deviation reporting.
  • Perform clinical supplies management with vendors on a country and regional level.
  • Ensure study-specific and corporate tracking systems are updated in a timely manner.
  • Act as the main communication line between monitor, site management associate, regional project lead, and project manager.
  • Coordinate planning of supervised monitoring visits and conduct visits.
  • Manage project team in site contracting and payments.
  • Lead project team calls on a country level as well as provide status updates and reports to regional lead/project manager.
  • Ensure ongoing evaluation of data integrity and compliance at a country/regional level.
  • Conduct site audit preparation visits, may participate in site audits, and coordinate resolution of site audit findings on a country/regional level.
  • Oversee project team in CAPA development and implementation.
  • Coordinate project team in process deviations review, management, and reporting.
  • Conduct initial training and authorization monitoring visits for monitors and act as a mentor for newly promoted lead CRAs.
  • Provide project-specific training and prepare training materials for the project team under supervision of a project manager and regional project lead.
  • Deliver trainings and presentations at investigator meetings.
  • Prepare, conduct, and report site selection, initiation, routine monitoring, and closeout visits.
  • Ensure that subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level.
  • Ensure accurate and timely information flow with trial sites on adverse events and protocol/process deviations.
  • Supervise source data verification and follow up on data queries at site level in the country/region; review and manage study risks on a site level.
  • Ensure proper handling, use, accountability, reconciliation, and return of all investigational product(s) and clinical study supplies on a country/region level.
  • Review essential study documents and supervise reconciliation of study investigator site file (ISF) / TMF at site level and country/region level.
  • Ensure data integrity and compliance at a site level.
  • Supervise site management associates in the flow of documents and laboratory supplies between the site and the central/regional lab/central reviewer.
  • Conduct project-specific training of site investigators.
  • Support 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).