Senior CRA (Oncology)

• Completes onsite and remote monitoring activities in accordance with all ICH-GCP guidelines, applicable regulations, SOPs and study processes. Activities include qualifying potential investigative sites, initiating clinical trials, maintaining study files, providing instructions to site personnel and study close out.
• Verifies the protection of study participants by confirming informed consent procedures and protocol have been performed in

• Ensures the integrity of clinical data and that the study is conducted in compliance with approved protocol, GCP, applicable

• Manages the investigative site staff to facilitate trial deliverables, e.g., subject enrollment, data deliverables.
• Verifies proper management and accountability of Investigational Product (IP).
• Writes and submits reports of investigational site findings and updates applicable tracking systems. Escalates observed

• Manages essential documents as required by local regulations and ICH-GCP guidelines before, during and after a clinical study; assists with resolution of investigational site/data queries.
• Performs key risk assessment and management responsibilities throughout the project, including key risk indicator and site health analysis, site process evaluation, and project escalation.
• Participates in audit preparation and follow-up activities as needed.

• Independently performs a variety of onsite and offsite monitoring visit types.
• Gathers and reviews information for assigned siteand identifies inconsistencies. With limitedguidance from project and

• Assists with non-complex adhoc, short-term assignmentin support of additional studies or departmental initiatives.
• May serve as preceptor, providing training to less experienced clinical team members

• Undergraduate degree or international equivalent in clinical, science, or healthrelated field from an accredited institution; health care professional licensure, i.e., registered nurse

• Previous experience supporting clinical trials including solid on-site monitoring experience.

• Travel is required 50-80%

• Equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated above. All employees must read, write and speak fluent English and host country language

• 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

ICON