As Clinical Project Administrator sponsor dedicated you will be integrated within the clinical team and provide instrumental support for the clinical trial.
What you will be doing: Partners with the LTM and Site Manager to ensure overall site management and adherence to internal SOPs, policies and local regulatory requirements.Supports the local study team in performing site feasibility and/or country feasibility.Maintains site level protocol information in Trial Management Systems (e.g. CTMS).In liaison with the LTM, ensures current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site within required timeframes.Works with investigational site staff to ensure accurate/complete regulatory documents are in place to expedite IEC/IRB or Health Authority approval process.Supports the Trial Manager and Clinical Monitor in providing the current and complete documents requested by the IEC/IRB and HA.Supports the TM & CM in collecting and maintaining all documents throughout the trial and post-trial in both eTMF (i.e., IF/LAF sections) and paper files.Distributes, collects, reviews, and tracks regulatory documents, agreements and training documentation.Collects and tracks Financial Disclosure information at appropriate time points.May contribute to process improvement including, but not limited, to representing functional area in process initiatives and contribute to optimization of daily processes.May be assigned as a coach and mentor to a less experienced CTA. You Are: Skills set corresponding with preferentially 2+ years relevant clinical trial experience or equivalent.Experienced in Clinical Trial Management Systems & TMF management.Experienced in Contracts management and negotiation.Proficient in English language.Strong knowledge with MS Office (Word, Excel, Access, Outlook, Explorer and PowerPoint).Strong interpersonal and negotiating skills.Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment.Perform activities in a timely and accurate manner. Benefits of Working in ICON:
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.
At 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.
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, 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.
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