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Site Management Associate

  1. Raleigh, Wilmington, Blue Bell, Charlottesville, Lenexa
JR101076
  1. Clinical Trial Support
  2. ICON Full Service & Corporate Support

About the role

This vacancy has now expired. Please click here to view live vacancies.

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.
 

What will you be doing?

 As a Site Management Associate, you are a primary point of contact/liaison for the sites, Sponsor and internal stakeholders during the study life cycle. You will perform investigative site communication, essential document collection and review, maintenance and close-out in-house site management activities in accordance with the Sponsor and/or ICON protocol, standard operating procedures (SOPs), ICH/GCP guidelines and all applicable regulatory requirements. You will work collaboratively with your study teams, sites, and clients. The Site Management Associate performs, essential document collection and review, clinical status tracking, in-house site management, and data review activities in accordance with the project protocol, client and/or ICON standard operating procedures (SOPs), and all applicable guidelines and regulatory requirements (e.g. ICH-GCP, and country/region specific)

  • Assists in identifying study sites by performing site feasibility and recruitment tasks, e.g., completing, disseminating and reviewing responses to site recruitment questionnaires.
  • Manages additional clinical operations tasks as required and outlined in study job task list.
  • Performs all tasks in accordance with applicable guidelines, (e.g., ICH-GCP), company and sponsor SOPs, project plan, study-specific processes, local regulatory requirements.
  • Performs risk assessment and management responsibilities throughout the project including site process evaluation, addressing follow up items and issue escalation.
  • Ensure timely and complete data entry by site.  Perform data review inclusive of site level data review, query resolution, facilitate database closure and freezing procedures as per study plans.
  • Acts as primary site contact/liaison for study and site management issues including addressing questions, inclusive of protocol questions, managing study supplies and conducting offsite central monitoring visits/contacts (pre-study, initiation, monitoring and close out visits). Escalates issues and risks as needed.
  • Sets up and maintains site-related data in applicable clinical systems according to procedures and guidelines.
  • Works with Informed Consent Form updates, collaborating with sites on updates and ensuring appropriate IRB submissions and approvals.
  • Collects essential regulatory documents from sites, and ensuring compliance with regulatory and ICH/GCP guidelines and ICON SOPs.


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.
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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