LATAM Clinical Research Specialist

1 dia atrás

Buenos Aires Espírito Santo Brazil beBeeClinical Tempo inteiro R$77.778 - R$98.319

Job Title: Central Monitor in LATAM

Job Description:

A key skilled and clinically experienced team member is sought after to join the Central Monitoring Department as a Central Monitor. This individual will provide remote project support and assistance across multiple projects, sites, and teams, while reviewing structured clinical data output with access to medical charts.

Key Responsibilities:
  1. 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.
  2. Ensure accurate completion and maintenance of internal systems, databases, tracking tools, and reports for project-specific information.
  3. Manage triggers and prepare i-site packs for respective sites and countries for assigned studies.
  4. Assist in developing basic data analytics scope and perform trend analytics for their respective studies.
  5. Participate in study team meetings and interact with cross-functional staff to verify information and triage new data issues or previously identified action items.
  6. Escalate quality issues pertaining to sites to the respective Centralized Monitoring Lead/Sr. Central Monitor.
  7. Perform Subject Level Data Review requiring further investigation with the clinical site to determine overall accuracy (inclusion & exclusion criteria, IP, AEs, Labs, EOT, EOS, End points, SAEs, etc.). Review other information as necessary to determine overall readiness of patient information for the next review level.
  8. Interact with sites/CRAs and follow-up on study milestones from start to closeout.
  9. Act as backup or perform activities delegated by the Central Monitor Expert/Centralized Monitoring Lead.
Requirements:
  1. Bachelor's degree in life sciences or related field, or nursing qualification; or near completion of degree.
  2. At least 2 years of relevant monitoring experience (on-site or remote).
  3. Advanced proficiency in Excel.
  4. Advanced level of English language skills.

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