Job Description

ICON Dedicated to a Single Sponsor

Mix of Oncology and Non-Oncology studies - Oncology experience preffered

• 15 sites sites
• Not all sites are enrolled
• Monitoring plan allows for flexibility for a higher number of sites/protocols however some plans only require 2 monitoring visits per year
• Sites – Primarily within driving distance
• 60% Travel – 8 visits per month
• mix of on-site and remote monitoring
• Utilizes risk-based monitoring.
• Requirements: Must have a four-year degree, completed all visits independently, and have two years of independent monitoring

What you will be doing:

Study Planning

• Contribute to the identification of new sites for clinical trials; analyse capability and support CRMA and CSM in making recommendation for trial inclusion.

• Assume ambassadorial role to facilitate communication between sites and CPO to increase value proposition to investigators.

• Facilitate the preparation and collection of site and country level documents during all phases of the trial. Supports the CSM in the oversight of Country and Site Trial Master Files (TMF). During all phases of the trial ensure archiving per relevant SOP.

• Negotiate investigator remuneration; prepare financial contracts between investigational sites and investigators. Ensure adherence to payment schedule.

Study Execution

• Implement complete site management including monitoring visits, regulatory assessment, drug supply management, etc. to ensure compliance with protocol, GCP, global and local regulations, global and local processes.

• Identify problems at sites; resolve issues and escalate as appropriate.

• Collaborate with the CSM to ensure recruitment and execute contingency plans, as needed.

• Complete preparation and generation of visit monitoring reports as per relevant SOP

• Review and manage data at site; resolve technical and content issues on a continuous basis in order to achieve timely database lock targets.

• If working with central CRAs (blinded and un-blinded), respond to alerts and follow-up to ensure resolution of issues

Study Close-out

• Implement site close-out activities and generate site close-out report.

• Provide feedback on site performance for future trial site feasibility/selection

General

• Improve skills by timely completion performance of assigned global and local training.

You are:

• Minimum 2 years prior monitoring experience with global trials.In-depth knowledge of FDA regulations and ICH/GCP guidelines
• Excellent interpersonal and communication skills (verbal & written), including proficiency in medical terminology and computer systems
• Ability to work effectively with investigators and other research personnel, maintaining a professional demeanor
• Ability to independently resolve site or study related issues
• Self motivated; detail oriented; team player; flexible
• Ability to prioritize workload to meet project timelines, while managing multiple protocols across therapeutic areas
• Excellent organizational and time management skills
• Function effectively with high degree of personal accountability
• CCRA or SoCRA certified

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:

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 .

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