Sr CTA

KCR Placement; Bell (CA); Sur place; USD 60 000 - 90 000; Plein temps

Avantages offerts par ce poste

Health insurance

Annual leave entitlements

Retirement planning

Employee assistance programme

Résumé du poste

ICON Strategic Solutions in the United States is seeking a Sr Clinical Trial Assistant to support clinical study teams, coordinate logistics, maintain regulatory files, and ensure timely study documentation in a sponsor-dedicated model.

You will interact with CROs and vendors, assist with meeting minutes, and help route contracts across Clinical Operations, legal, and finance, leveraging 2-5 years of clinical research experience.

Qualifications

• Bachelor’s degree or equivalent undergraduate degree with science or healthcare experience preferred.
• 2-5 years clinical research experience in a pharmaceutical/biotech, CRO setting preferred.
• Basic knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials.
• Strong interpersonal, organizational, and multi-tasking skills.
• Excellent attention to detail and problem solving skills.
• Self-motivated and displays initiative.
• Perform job duties with minimal supervision and guidance.
• Ability to work effectively in a team setting.

Responsabilités

• Coordinate, logistics, tracking and administrative tasks in support of clinical trials.
• Track study status, enrollment, regulatory documentation, and site start-up status for assigned clinical projects.
• Filing, review and reconciliation of electronic Trial Master Files.
• Review of study documentation, including study plans and regulatory packs.
• Support and/or track external access rights to clinical study systems.
• Interact with CROs, vendors, investigators, monitors and other external partners.
• Assist CTA/CTM with meeting minutes for clinical meetings.
• Assist CTA/CTM with logistics coordination for investigator and external vendor meetings.
• Route, tracking, and coordinating site and CRO/vendor contracts with Clinical Operations, legal, and finance departments.

Connaissances

Clinical research

GCP/ICH knowledge

Organizational skills

Attention to detail

Teamwork

Multitasking

Formation

Bachelor’s degree in science/healthcare

Description du poste

Sr Clinical Trial Assistant

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

What You Will Do:

• Clinical study team member: works closely with the Clinical Study Team and is responsible for coordination, logistics, tracking and administrative tasks in support of clinical trials.
• Tracks study status, enrollment, regulatory documentation, and site start-up status for assigned clinical projects.
• Responsible for filing, review and reconciliation of electronic Trial Master Files.
• Review of study documentation, including study plans, site start-up regulatory pack reviews, monitoring visit reports, ICF documents, etc.
• Supports and/or tracks external access rights to clinical study systems.
• Interacts with CROs, vendors, investigators, monitors and other external partners to provide information and resolution for specific requests and issues.
• Assists CTA/CTM with meeting minutes for clinical meetings.
• Assists CTA/CTM with logistics coordination for investigator meetings and external vendor meetings.
• Responsible for routing, tracking, and coordinating site and CRO/vendor contracts with Clinical Operations, legal, and finance departments.

Your Profile:

• Bachelor’s degree or equivalent undergraduate degree with science or healthcare experience preferred
• Experience: 2-5 years clinical research experience in a pharmaceutical/biotech, CRO setting preferred
• Basic knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials
• Strong interpersonal, organizational, and multi-tasking skills
• Excellent attention to detail and problem solving skills
• Self-motivated and displays initiative
• Perform job duties with minimal supervision and guidance
• Ability to work effectively in a team setting

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 maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

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.

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