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Clinical Research Associate II
2 months ago
We are seeking a highly skilled Clinical Research Associate II to join our Oncology team. As a key member of our team, you will be responsible for monitoring and managing clinical trials, ensuring compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines.
Key Responsibilities- Monitor and manage multiple oncology trials, with a focus on quality of life and regional travel.
- Develop and implement site startup documents, including SIV agendas, and provide training to site staff.
- Act as a lead site manager, training and mentoring junior team members, and representing the team in meetings and discussions.
- Provide input on study documents, such as monitoring guidelines, and ensure compliance with regulatory requirements.
- Support country budget development and contract negotiation, working closely with CCS colleagues.
- Assist with adverse event reporting and ensure compliance with quality metrics and KPIs.
- Minimum of 3 years' experience in monitoring pharmaceutical industry clinical trials, with a focus on oncology.
- Strong analytical and risk-based monitoring skills, with experience in using various systems and databases.
- Excellent communication and influencing skills, with the ability to work independently and as part of a team.
- Strong knowledge of GCP, ICH guidelines, and local regulatory requirements.
- Ability to travel up to 50%.
At ICON, we offer a competitive salary and a range of benefits, including annual leave entitlements, health insurance, retirement planning, and a global employee assistance program. We are committed to diversity, inclusion, and belonging, and offer a workplace free of discrimination and harassment.
Interested in this role? We encourage you to apply, regardless of whether you meet all the requirements. We are looking for talented individuals who can contribute to our team's success.