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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 managing clinical trials, ensuring compliance with regulatory requirements, and providing exceptional support to our investigators and site staff.
Key Responsibilities- Manage multiple oncology trials, focusing on quality of life and regional travel
- Develop and implement site start-up documents, including SIV agendas
- Provide subject matter expertise on study documents, such as Monitoring Guidelines
- Represent LTMs or SMs on SMTs and meetings
- Take over LTM role reports review for sites assigned to other SMs from the same trial
- Support country budget development and contract negotiation with CCS colleagues
- Assist with ASV and metrics/KPIs outlined in the Quality Oversight Plan (QOP) document
- Primary interfaces: Provider Functional Manager, Clinical Trial Assistant, Local Trial Manager, and Central Study Team
- Other interfaces: Study Responsible Physician, Regional Quality and Compliance Manager/Specialist, Local Drug Safety Officer, and Site Manager team
- Based in Tennessee, near a major airport
- Minimum of a B.Sc., R.N., or equivalent degree, preferably in Biological Sciences
- Minimum of 3 years' experience in monitoring pharmaceutical industry clinical trials
- Minimum of 1-3 years' experience monitoring Oncology trials
- Knowledge of several therapeutic areas, with Oncology an asset but not a requirement
- Analytical/risk-based monitoring experience is an asset
- Ability to drive patient recruitment strategies at assigned sites
- Ability to partner closely with investigator and site staff to meet study timelines
- Ability to operate and use various systems and databases
- Possess strong communication and influencing skills
- Have an in-depth knowledge of Good Clinical Practice, ICH guidelines, and local regulatory requirements
- Need to travel up to 50%
At ICON, we value diversity, inclusion, and belonging. Our rich diversity makes us more innovative, which helps us better serve our people, patients, customers, and communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation.
We're committed to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
