Centralized Monitor/Centralized Monitor Coordinator
IQVIA
Buenos Aires, Argentina
hace 6 días

PURPOSE

A Central Monitor Assistant is a key skilled and clinically experienced team member of IQVIA Central Monitoring Department.

A CM provides remote project support and assistance across multiple projects, sites and teams and reviews the structured clinical data output with access to medical charts.

RESPONSIBILITIES

  • Perform centralized monitoring activities on assigned projects and evaluate the quality and integrity of the study as per the protocol, SOPs, respective regulations and guidelines.
  • Ensure accurate completion and maintenance of internal systems, databases, tracking tools / reports for the project specific information.
  • Perform Management of triggers and preparation of i-site pack for respective sites and countries for assigned study(ies).
  • May assist in Developing required basic data analytics scope and performing the trend analytics for their respective study(ies).
  • Participate in (study) team meetings and interaction with cross functional staff to verify information and / or triage new data issues or prior identified action items.
  • Escalate quality issues pertaining to site to respective Centralized monitoring lead / Sr. Central Monitor.
  • May perform Subject Level Data Review that require further investigation with the clinical site to determine overall accuracy (inclusion & exclusion criteria / IP / AE / Labs / EOT / EOS / End points / SAEs etc.
  • Review any other information as necessary to determine overall readiness of the patient information for next level review

  • Interaction with sites / CRA and follow-up on study required milestones from the project start until close out.
  • May act as backup / perform the activities as per the task list delegated by Central Monitor Expert / Centralized Monitoring Lead
  • MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • You must have a Bachelor's degree in life sciences or related field, or nursing qualification; or be near to obtain the degree.
  • At least 2 years of relevant clinical research experience.
  • Advanced English Level (mandatory)
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