ICON Clinical Research

Senior Study Support Assistant - home or office based EMEA

Location
London
Salary
Competitive
Posted
07 Apr 2021
Closes
07 May 2021
Ref
JR070972
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Senior Study Support Assistant : home based - EMEA

At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.

Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That's our vision. We're driven by it. And we need talented people who share it.
If you're as driven as we are, join us. You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.

Job Profile Summary



  • * To independently assist the Study Start Up team in ensuring the most effective and efficient study start up by providing administrative and tracking support

    * To independently assist the Study Start Up team with study maintenance activities by providing administrative and tracking support.

    * To assist the Study Start Up team in the completion of all required tasks to meet departmental and project goals.

    * To co-ordinate metrics collection and other Study Start Up activities, as assigned.

    Job Description



  • * Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.

    * As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

    * Travel (approximately 5%) domestic and/or international
    * Provide general administrative support to the Study Start Up team

    * Support the Study Start Up Lead including tracking, filing and other coordinating tasks

    * Assist Study Start Up team with submission documentation and guidelines, as appropriate

    * Collate and verify, for completeness, submission documentation for submission to the Regulatory/Competent Authority (CA) /Ethics Committee (EC) and other relevant authorities

    * Co-ordinate, dispatch and track submissions to CA/EC and other relevant authorities

    * Assist in the translation and co-ordination of translations for documents required for submission to CA/EC and other relevant authorities.

    * Assist Study Start Up team with submission progress tracking by updating the relevant ICON/Sponsor tracking system, as required

    * Copy and route incoming correspondence, internal documentation etc, as appropriate

    * Be familiar with ICH GCP and relevant ICON SOPs

    * Be competent with ICON/Sponsor Clinical Trials Management System (CTMS), as appropriate

    * Set up, organize and maintain Study Start Up electronic filing systems

    * Assist in co-ordination of payments to CA/EC and other relevant authorities, as appropriate

    * Set up and organize meetings, as requested

    * Attend Study Start Up team meetings and generate meeting minutes

    * Assist in the production of slides, overheads, etc., as needed for team meetings, departmental, sponsor and/or business development presentations

    * Assist in other related Study Start Up tasks under the direction of the Study Start Up manager, as required

    * Be familiar with the roles of the Study Start Up Associates including submission requirements and timelines, in relevant countries

    * Under supervision of an Study Start Up Associate, prepare, review and submit notifications and amendments, as assigned

    * Assist Study Start Up Management in coordinating team activities, including confidential tasks

    * Assist in other related Study Start Up tasks under the direction of the Study Start Up Manager, as required.



Benefits of Working in ICON:
Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON 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, 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 through the form below.

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