Senior Study Support Assistant

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 Senior Study Support Assistant is responsible for assigned project site start-up and qualification activities per study specific requirements. Additionally, the Senior Study Support Assistant will provide support to sites for the life of all assigned projects. This role will maintain all site qualification documentation using Good Clinical Practice and Good Documentation Practices and will enter and/or update the site database with relevant site information. The Senior Study Support Assistant will schedule all site trainings, maintain the training database for studies utilizing online training and build strong relationships with sites and internal departments. The Senior Study Support Assistant supports Project Management on customer calls during the site start up process, as well as maintains the site tracking spreadsheet sent to the sponsor during the site qualification process. The Senior Study Support Assistant will work with Documentation and Training to ensure that study requirements are in alignment and communicated to the sites accordingly. The Senior Study Support Assistant is also responsible for site closeout and requesting and tracking the return of any equipment that may have been deployed during the study. The Senior Study Support Assistant may carry a mixed portfolio of Imaging and Cardiac studies of varying complexity as assigned by the Manager, Site Management and will work with moderate oversight.

Essential Duties/Responsibilities:

• Establishing and maintaining strong working relationships with site contacts and internal departments
• Serving as main point of contact for Imaging and/or Cardiac sites participating in Clinical Trials
• Providing site support via email and telephone
• Generating and documenting all site communications associated with the Site Qualification process from initial contact to First Participant Ready status
• Providing sites their necessary access credentials
• Maintaining an audit ready file documenting the qualification process for all sites
• Ensuring weekly status follow ups are completed on time and entered in the site database
• Entering and updating site information in the site database as needed throughout the study
• Maintaining study specific site qualification trackers for sponsors
• Providing support and site updates on internal/external Kick Off meetings and weekly teleconferences
• Collaboration with Documentation & Training to ensure study requirements are in alignment and communicated with sites accordingly
• Request/track sites return equipment at study close
• Providing daily and weekly metrics for completed activities to management
• Creating unique project specific templates for site communication
• Proactively communicating with Project Management if issues or concerns arise that may impact site qualification
• Managing special projects and programs assigned by the Manager, Site Management

What ICON can offer you:

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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.

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