Overview
Study Start-up Associate ensures that patients will have access to our clinical trials with the aim of making life better for our patients. The Associate is accountable for obtaining all approvals (Competent Authority and Ethical Review Board) to run the trial in the EMEA and AMERIT Regions. The Associate will also have responsibility to ensure the investigator sites meet the requirement to enroll the study participants in the clinical trial and support maintenance and closeout activities. The Associate will ensure inspection readiness through a complete, accurate and readily available Trial Master File. Additional local responsibilities may be required as needed/appropriate for the local geography and/or to cover regional differences.
Responsibilities
What you will be doing:
- Initiate investigator site activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents, serve as the point of contact for a site’s ERB and Competent Authority (CA)(where applicable), track and ensure site compliance to required training, and effectively drive timelines aligned with company priorities
- Communicate directly with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out
- Maintains current knowledge of relevant country regulations, and GCP and ICH Guidelines for clinical research.
- Create, review and customization of country/site specific Informed Consent Forms (ICFs).
- Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems
- Leverage previous site / review board engagements to efficiently drive new work
- Understand and comply with procurements, legal and financial requirements, and procedures
- Populate Trial Master Files and libraries for future reference
- Provide feedback and shared learning for continuous improvement
Qualifications
You are:
- Applied knowledge of project management processes and skills
- 2-5 years’ experience in clinical development, with some experience in clinical research/
- Involvement in cross-functional clinical trials/experience in supporting the operational activities of clinical trials.
- Appreciation of / experience in compliance-driven environment
- Effective communication, negotiation, and problem-solving skills and demonstrated ability to meet timelines.
- Self-management and organizational skills.
-
Knowledge of Good Clinical Practice and understanding of the overall drug development
process.
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- 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
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated 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.
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