Study Start Up Associate Ii Job in Icon Plc

"At ICON, it's our People that set us Apart"

ICON plc, a leading global Contract Research Organization employing 15,000 people in 40 countries. ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.

About the SSUA II, SSU Services at ICON

* *Perform feasibility, site identification, site contract negotiation, and other study start up activities, as assigned

* *Prepare, review and submit submissions to CA, EC and other relevant authorities in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct.

This includes, but it is not limited to:
* ethics/regulatory/other relevant authority approvals for clinical trials

A Symbol of Excellence

* ethics/regulatory/other relevant authority approvals for trial amendments
* ethics/regulatory/other relevant authority study notifications
* authorizations for import/export of investigational products, clinical supplies and biological samples
* approvals from the national authorities for data protection

* *Review and translate Drug Labels

* *Advise Sponsor on knowledge content for development of Drug Labels

* *Perform independent quality review of submission packages

* *Responsible for the collection and maintenance of the current Regulatory/Competent Authority (CA) and Ethics Committee (EC) submission information, and similar information for other related organizations, for the assigned countries and update relevant ICON information system

* *Responsible for the translation and co-ordination of translations for documents required for submission

* *Perform timely and accurate data entry of regulatory documents, submission status and maintenance of Country/Investigator information in the appropriate clinical trial management system

* *Copy and route incoming correspondence, internal documentation, etc., as appropriate

* *Responsible for the timely follow-up for queries made by EC/CA

* *Responsible for the collection of critical documents required for IP Release

* *Attend study team meetings as required (maybe discretionary), including Kick-Off Meetings which are mandatory

* Assemble and distribute study materials to Clinical and Project teams, including materials to study sites and Investigator Meetings (e.g.; investigator binders) and vendors, as appropriate

* *To be familiar with ICH GCP, relevant country regulations/guidelines and ICON SOPs

* Competent in communication skills for timely follow-up, issue resolution and report updates; as outlined in the communication and escalation plan with timely documentation

* To undertake other reasonably related duties as may be assigned from time to time.

Benefits of working at ICON:

ICON offers an exceptional benefits package that includes a comprehensive health plan, retirement plans, highly competitive pay, corporate bonus plan, time away from work, and other incentives. We provide you with the technology, innovation and resources to be successful in ensuring utmost compliance and operational efficiencies