Parexel is looking for multiple Site Monitors (CRA I, II) and SR CRA in Chile, Argentina, Brazil and Mexico.
The Site Monitor (CRA) will be responsible for data integrity, data quality and ensuring compliance with ICH GCP and local requirements at the site level.
Monitoring will be conducted in line with the Study Monitoring Plan and will be performed virtually for the majority of activities to supplement on-site visit requirements.
The Site Monitor will collaborate with the Site Manager to assure that the site is in compliance with the protocol and is inspection ready.
The Senior Clinical Research Associate (sCRA) is a study-level role, working on specific, assigned protocols with assigned investigative sites.The sCRA will coordinate with the Site Care Partner to transition site management accountability at the point of the site initiation/activation.The sCRA will be responsible for data integrity, data quality and ensuring compliance with ICH GCP and local requirements at the site level through study conduct and close-out. Monitoring will be conducted in line with the Study Monitoring Plan and will be performed virtually for the majority of activities to supplement on-site visit requirements.
Education
Experience
For the Site Monitor I a minimum of 12 months experience as a clinical monitor with demonstrated experience of monitoring (virtual or onsite). For the Site Monitor II a mininum of 3 years, and for the SR CRA a minimun of 4 years of experience as a clinical monitor with demonstrated experience of monitoring (virtual or onsite).
Skills and Technical Competencies
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
Demonstrated networking and relationship building skills
Ability to communicate effectively and appropriately with internal & external stakeholders
Ability to adapt to changing technologies and processes
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