Clinical Study Associate - Medical Device - Irvine (Hybrid)

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

The Clinical Study Administrator will assist with processing, tracking, and filing of study documents, and management of  the Trial Master File within the clinical projects.  Additionally, services  will include administrative support of clinical study staff, as required.  Supports project managers within the assigned clinical studies.

• Services rendered will adhere to applicable Client SOPs, WIs, policies, local regulatory requirements, etc.
• Maintain and track relevant activities in CTMS in partnership with Study Teams.
• Creates and distributes regulatory binders.
• Tracks, in a timeline manner, essential study documents and ensures completeness of the Trial
• Master File for assigned clinical studies according to appropriate regulations, departmental guidelines, and work instructions
• Distributes safety documentation to other functional groups in support of safety committee meetings as requested (supporting role).
• Creates and generates system reports.
• Supports creation, ordering and distribution of study supplies to sites (e.g. print protocols, burn DVDs).
• Assists with Device tracking and ordering, if required and if applicable.
• Assists with logistics for Investigator meetings/expert panel meetings. Metrics/KPls governing these services are outlined in the Quality Oversight Plan (QOP) document.
• Metrics/KPls: Metrics/KPls governing these services are outlined in the Quality Oversight Plan (QOP) document.

#LI-AS3

What do you need to have?

• Must have Bachelor's Degree
• Requires previous administrative support experience or equivalent for at least 1 year.
• Previous clinical research experience a plus.
• Clinical/medical background a plus
• Requires experience and knowledge working with computer systems (Microsoft office - Excel, Word and Power Point).

Pay Range $45,864.00/Yr. USD - $57,330.00/Yr. USD

Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level.

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/benefitsICON, 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.