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Study Start Up Associate

4 months ago

Shefford, United Kingdom ICON Plc Full time

Study Start Up Associate / Regulatory Submissions

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.

Study Start Up Associate / Regulatory Submissions

As a member of the Study Start Up Team, you will play an integral role in making sure that physicians at our research sites are prepared to start the trial of investigational, new pharmaceutical and biological products for clinical trials at their local practices.
 

Prepare Country template of Subject Information Sheets (SIS) and Informed Consent Forms (ICF). Prepare and submit study submission package to Ethics Committee (EC) and MoH. Including response to queries. Prepare and submit maintenance submissions. Effective interaction with Ethics Committees, MoH and sites to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct (start up and maintenance as assigned). Forecast submission/approval timelines and ensure they are achieved; provide risk and contingency plans to mitigate impact if forecasted timelines are at risk, and escalate issues as soon as identified. Prepare and submit Critical Document Package (CDP). Review and negotiate clinical site investigator contracts and budgets. Stay connected with Investigative sites, sponsors and internal personnel regarding the status of contracts and contract-related documents

What you need
• A bachelor’s degree in Paralegal Studies, Juris Doctor (law) degree, or related experience is preferred.
• SSU or Contracts experience at a CRO is desired.
• Experience in a clinical research environment with specific experience in study contracts review and budget negotiation or in related field such as where contract or legal document review is a primary part of you role.

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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