The CRA monitors that a study is conducted according to the protocol, ICH-E6 (R3) Good Clinical Practice and local regulations: site selection, initiation, monitoring and close-out visits, source data verification and review (SDV/SDR), and identification of protocol deviations. For sponsors and CROs running studies in Latin America, the CRA is also the bridge between global study teams and local sites.
Define the profile
- · Therapeutic area and study phase.
- · Junior or senior, depending on the level of autonomy required.
- · On-site, remote or hybrid monitoring, and expected travel.
- · Countries to cover and their regulatory frameworks.
- · English level for global team meetings, reports and systems.
What to assess
- · Judgement in real-life scenarios, not only theoretical knowledge.
- · Communication with site staff, often in Spanish or Portuguese, and with global teams in English.
- · Quality and timeliness of visit reports.
- · Hands-on experience with CTMS, EDC/eCRF and IRT systems.
Common mistakes
- · Asking for a senior profile for junior-level tasks.
- · Screening on CV keywords only.
- · Underestimating local regulatory knowledge.
ECR Talent supports CRA searches for CROs, pharmaceutical and biotech companies and clinical research sites across Latin America.
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