CRA II or Sr CRA (sponsor dedicated) - Min 3 years of prev exp in monitoring - Santiago, home-based
Remote · Santiago, Santiago Metropolitan, Chile
Job Summary
CRA II or Sr CRA responsible for site qualification, initiation, interim and ongoing monitoring, and site management (on-site or remote) with strict adherence to regulatory, ICH-GCP and GPP standards. Responsibilities include verifying informed consent, conducting source document review and CRF data verification, resolving data queries, supporting IP inventory and labeling, ensuring ISF/TMF accuracy, and training site staff. The role supports subject recruitment and retention, collaborates with sponsor teams, and may travel up to 75% (Real World Late Phase context). Requires a Bachelor’s degree or RN in a related field (or equivalent) with strong communication and computer skills; familiarity with ICH-GCP and regulatory requirements is essential. The posting indicates a real opportunity pipeline rather than a live role.
Required Qualifications
- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Must demonstrate good computer skills and be able to embrace new technologies
- Excellent communication, presentation and interpersonal skills
- Ability to manage required travel of up to 75% on a regular basis
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