Lead Clinical Research Associate

19 hours ago

North Sydney Council, Australia IQVIA Full time

North Sydney, Australia | Full time | Hybrid | R1520206

Job available in additional locations

Lead CRAs will be assigned to different studies conducted in one or more countries to deliver and progress the assigned studies.

The Lead CRAs will also be assigned as CRA to one study site as a minimum to verify an adequate understanding of sponsor requirements, procedures, and systems. Thus, requiring the CRA to have more than 3-5 years of onsite monitoring experience. Previous roles and experience in clinical lead would be beneficial.

The main responsibilities of the Lead CRA are:

  • To oversee the overall study monitoring plan compliance for the studies and countries assigned.
  • To serve as the primary point of contact for IQVIA CRAs and sponsor Project manager for any study monitoring-related questions or concerns.
  • To provide oversight of site monitoring data management activities (entails pulling data management reports and leading the follow-up on missing pages, outstanding queries, etc.).
  • To review Monitoring Visit Reports and advise CRAs on any study-related questions. Initially, 100% MVR review is expected, moving in the future to a risk-based approach after consultation and agreement with sponsor Project Manager.
  • To prepare, lead, and follow up on regular meetings (frequency to be determined by the Project Manager and Lead CRA for each of the studies) with the IQVIA CRA and sponsor Project Manager to review study status, risks, trends, upcoming data timelines, etc.
  • To collaborate and liaise with sponsor Project Manager for project execution support as appropriate.
  • To support CRA with study issue resolution.
  • To report any staff performance concerns to the CRA's manager.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more

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