ICON Hiring Study Start Up Associate / Study Start Up Manager
About the job
Study Start Up Associate I / Senior SSUA / Study Start Up Manager
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 or related experience is preferred
• SSUA I : 1-2 years of working experience as a study coordinator, CTA, Start up Specialist or relevant areas
• Senior SSUA : at least 4+ years of start up experience is required.
• 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