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Clinical Research Professional
2 weeks ago
Company Overview
As a leader in the clinical research industry, ICON is dedicated to delivering high-quality results and exceptional service to our clients.
We are seeking a highly skilled Clinical Research Associate to join our team and contribute to the success of our projects.
Job Description
- Oversee multiple oncology trials, ensuring timely and accurate execution
- Provide leadership and mentorship to junior team members, promoting a culture of excellence and collaboration
- Act as Lead Site Manager, training and guiding other site managers on study protocols and best practices
- Develop essential study start-up documents, including SIV agendas and ensure compliance with Good Clinical Practice (GCP)
- Represent Site Managers and Lead Trial Managers in key meetings, advocating for the needs and perspectives of site staff
- Ensure the site manager perspective is reflected in study documents, such as Monitoring Guidelines
- Review reports (SQV, SMV, SCV) for sites assigned to other site managers within the same trial, identifying areas for improvement and implementing corrective actions
- Support country budget development and contract negotiations in collaboration with CCS colleagues
- Assist with ASV activities and ensure alignment with study objectives
- Maintain compliance with Metrics/KPIs as outlined in the Quality Oversight Plan (QOP)
Required Skills and Qualifications
- Minimum of a B.Sc., R.N., or equivalent degree, preferably in Biological Sciences
- At least 2 years of experience monitoring clinical trials in the pharmaceutical industry
- Experience in multiple therapeutic areas is an asset, particularly in oncology (Hematology, Prostate Cancer, Lung Cancer, Early Development - Phase 1)
- Knowledge of risk-based/analytical monitoring approaches is an asset
- Proficiency in clinical trial systems such as CTMS, EDC, TMF, IWRS, and safety reporting tools
- Ability to actively drive patient recruitment strategies at assigned sites
- Strong collaboration with investigators and site staff to meet study timelines
- Effective communication and influencing skills to manage study sites effectively, both remotely and in-person
- Ability to work independently while being a strong collaborator
- In-depth understanding of Good Clinical Practice (GCP), ICH guidelines, and local regulatory requirements
Benefits
- Competitive salary and benefits package
- Opportunities for professional growth and development
- Collaborative and dynamic work environment
- Flexible work arrangements and remote work options
- Access to cutting-edge technology and tools
