• Monitor and own the progress of clinical studies at investigative sites
• Ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards
• Coordinate all necessary activities required to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.)

Requirements

Graduate or postgraduate degree with a concentration in a scientific or healthcare discipline
At least six months of CRA experience (including 6 months of independent monitoring) within the CRO or pharmaceutical industry
Availability for domestic travel including overnight stays, which may constitute up to approximately 50-60% travel commitment (international travel may be required for some senior level positions)
Fluency in English and for non-English speaking countries the local language of country where position based
Experience in oncology and pulmonology studies (Preferred)
Study start up activities experience (Preferred)

🔍 ATS Optimization Keywords
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Hard Skills

clinical study monitoring
regulatory submissions
pre-study visits
initiation visits
ICH-GCP
SOPs
oncology studies
pulmonology studies
CRA experience
study start up activities

Soft Skills

communication
organizational skills
interpersonal skills
independent monitoring
availability for travel

Certifications & Qualifications

graduate degree
postgraduate degree

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