Clinical Study Associate - Medical Device - Irvine (Hybrid)

As a Clinical Study Administrator you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

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.

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.

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

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.

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.