ICON Strategic Solutions
What you will be doing:
- Act as liaison between the in-house team, vendors, and multiple clinical sites.
- Work collaboratively with investigative sites to develop strong, long-term, working relationships.
- Apply SOPs, Clinical Monitoring Plan (CMP), study manuals and other materials and guidelines as applicable.
- Help identify and qualify potential investigators. Perform Pre-Study Site Visits.
- Assist with start-up activities, including essential document review and collection as requested.
- Perform Site Initiation Visits.
- Provide initial and ongoing training to site personnel regarding the study protocol, applicable policies/procedures, and GCP.
- Perform Interim Monitoring Visits for assigned studies:
- Monitor site compliance with study protocol, and GCP.
- Perform source data review and verify adequacy of clinical data through comparison of case report forms to source documents per CMP.
- Ensure the site is entering data according to the CRF Completion Guidelines and meeting data entry and query resolution deadlines.
You are:
- BA/BS, or equivalent, or relevant experience and training with at least 6 years of pharmaceutical/biotech experience. RN or health care professional preferred.
- Prior monitoring experience is required. Oncology/hematology clinical trial experience is preferred.
- FDA/EMA inspection experience is preferred.
- Proficiency in CFR and GCP/ICH Guidelines is required. Experience working on global clinical trials is preferred.
- Proficiency in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint) and other electronic systems (CTMS, EDC and eTMF).
- Excellent communication and organizational skills.
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:
- 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
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
To apply for this job please visit careers.iconplc.com.