Description:
* Partners with the CTM and CRA 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 CTM, ensures current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site within required timeframes.
* Where applicable, works with investigational site staff to ensure accurate/complete regulatory documents are in place to expedite IEC/IRB or Health Authority (if applicable) approval
* Supports the CTM or, where applicable the CRA, in providing the current and complete documents requested by the IEC/IRB and HA.
* Supports the CRA/CTM in collecting and maintaining all documents throughout the trial and posttrial in both eTMF(i.e., IF/LAF sections) and paper files.
* Distributes, collect, review, and track regulatory documents, agreements and training documentation.
* Collects and tracks Financial Disclosure information at appropriate time points.

Profile:

* Skills set corresponding with preferentially +2 years relevant clinical trial experience or equivalent.
* 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.

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Why join the DOCS team at ICON?

Working at ICON is more than a job, it's a calling for people who care and are passionate about improving patients' lives. At ICON, we care about our people and your passion, you are key to our success. We aim to provide an open and friendly work environment where we empower our people and provide them with opportunities to develop their long-term career.
It takes courage to move from one job to another, the process involves careful consideration. Reach out having the conversation that would change your life and the lives of our patients. Our team of recruitment experts will provide the information you need in making the right decision.