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 II
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.
The Role
* Collect, prepare, review, approve, process and track regulatory and site level critical documents required for study site activation in accordance with ICON SOPs/WPs, Sponsor SOPs, applicable country regulations/guidelines and the principles of ICH/GCP. This may include:
- Prepare, review and approve Subject Information Sheets (SIS) and Informed Consent Forms (ICF)
- Prepare, review and negotiate Clinical Trial Agreements, budgets and any required ancillary agreements with assigned Study Sites, including the facilitation of the indemnification process, between Sponsor and Study Site.
- Collect, review, organize and assemble regulatory initial start-up and maintenance submission packages to Central EC/IRB, Local EC/IRB, Competent Authorities, any other local regulatory authorities as required by countries.
- Essential Country and Site document collection and review, ensuring that Sponsor and Investigator obligations are being met and are in compliance with applicable country requirements.
* To 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
* Prepare and coordinate preparation of contractual documents and correspondence
* Facilitate the indemnification process between the study sponsor and the site.
* Function as the internal consultant on study budgets (investigator payments, develop and update training documentation and conduct group training as necessary, mentor and train new and junior personnel in the SSU department, and act as consultant on the Investigator Contract and Budget development process from origination through execution).
What you need ;
* A bachelor's degree in Life Sciences, Paralegal Studies, Juris Doctor (law) degree, or related experience is preferred
* Minimum 2 year of study start up experience is desirable.
* CRA experience can be a plus.
* 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.
* Fluent in English writing and speaking
* Computer literate
Benefits of Working in ICON :
Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.
ICON is an equal opportunity employer, including disability/veteran, and committed to providing a workplace free of discrimination and harassment.