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Clinical Research Associate
2 months ago
Position Overview:
The role of the Clinical Research Associate (CRA) I/II in Oncology is pivotal in ensuring the successful execution of clinical trials focused on cancer research. This position requires a minimum of one year of independent onsite monitoring experience, specifically within the oncology field.
Key Responsibilities:
- Manage multiple oncology trials with a focus on enhancing quality of life.
- Engage in regional travel to oversee trial sites effectively.
- Exhibit leadership qualities by participating in specific initiatives and serving as a Subject Matter Expert (SME) for various systems and processes.
- Provide mentorship and coaching to junior team members.
- Assume the role of Lead Study Monitor, training other Study Monitors on the project.
- Prepare essential site startup documentation, including Site Initiation Visit (SIV) agendas.
- Contribute the Study Monitor's perspective during the review of study documents, such as Monitoring Guidelines.
- Represent Lead Trial Managers (LTMs) or Study Monitors in Study Management Teams (SMTs) and meetings.
- Take responsibility for reviewing reports (SQV, SMV, SCV) for sites assigned to other Study Monitors within the same trial.
- Assist in the development of country budgets and contract negotiations in collaboration with CCS colleagues.
- Support the execution of Audits and Site Visits (ASV).
Performance Metrics:
The effectiveness of these services will be measured against the Metrics and Key Performance Indicators (KPIs) outlined in the Quality Oversight Plan (QOP) document.
