Site Monitor II - Oncology

Yesterday

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Parexel

Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions

10,000+

💰 Venture Round on 1990-01

Description

• Responsible for data integrity, data quality and ensuring compliance with ICH-GCP and local requirements. • Monitoring will be conducted virtually for most activities to supplement on site visit requirements. • Collaborate with the Site Manager and ensure compliance with the protocol and inspection readiness. • Coordinate with institutions and investigators, and collaborate with SOM, GSM, and SCP. • Opportunity to work on oncology studies for one of the top 10 pharmaceutical companies in the world.

Requirements

• Bachelor’s degree or Registered Nurse (RN) in a related field or equivalent combination of education, training, and experience. • A minimum of 3 years' experience as a clinical monitor with demonstrated experience of monitoring (virtual or onsite). • Minimum 3 years' experience monitoring oncology trials. • Experience of utilizing systems like Siebel clinical trial management system (CTMS), electronic Trial Master File (eTMF), and electronic Investigator Site File (eISF) (Florence). • Experience in managing complex protocols in Oncology or other therapeutic areas (TA’s) where protocols are determined to be high risk. • Proficiency in local language is required. • English proficiency is required. • Ability to manage required travel of up to 75% on a regular basis. • Current driver’s license required.

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