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Company

ICON Strategic Solutions · 16 hours ago

CRA II

United States

Full-time

Remote

Mid Level

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Pharmaceuticals

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Responsibilities

Conducts in-house monitoring, and may independently perform on-site monitoring in accordance with Roche and Ventana Standard Operating Procedures, ICH GCP guidelines and Regulations

Participates in assessing study risks and risk based monitoring

Communicates directly with investigators and site staff

Prepares clinical study monitoring plan and may provide input into study budgets

Qualification

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Point of Care experienceClinical Practices (cGCP)Experimental designs knowledgeMicrosoft WordMicrosoft ExcelMicrosoft AccessMicrosoft PowerPointMicrosoft VisioRecord keeping skillsTime management skills

Required

Point of Care experience

Conducts in-house monitoring, and may independently perform on-site monitoring in accordance with Roche and Ventana Standard Operating Procedures, ICH GCP guidelines and Regulations

Participates in assessing study risks and risk based monitoring

Communicates directly with investigators and site staff

Prepares clinical study monitoring plan and may provide input into study budgets

Excellent skills in basic computer applications (Word, Excel, Access, PowerPoint, Visio)

Excellent writing and verbal communication skills

Well organized and detail oriented

Impeccable record keeping and filing skills

Excellent time management skills

Ability to give presentations and teach others

Ability to work effectively in a team, and also work independently on assigned tasks

Knowledge and understanding of current Good Clinical Practices (cGCP) and Regulations

Knowledge of typical experimental designs to characterize the performance of an IVD or Medical Device

Benefits

Various annual leave entitlements

A range of health insurance offerings to suit you and your family’s needs

Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead

Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being

Life assurance

Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others