As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry! Are you one of them?
At ICON, we have an incredible opportunity for a Study Start-up Associate to join the team.
* Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
* As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes, adding value to our business and meeting client needs.
* Travel (approximately 5%) domestic and/or international. Anticipated activities may include attendance at Kick-Off, Investigator or study team meetings.
* Perform feasibility, site identification, site contract negotiation, and other study start up activities, as assigned.
* Prepare, review and submit submissions to ethics and regulatory 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
* 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
* Develop and finalize Country Specific SIS/ ICFs.
* Prepare and finalize Country Specific xml files (if applicable for region).
* Review and translate Drug Labels.
* Perform independent quality review of submission packages.
* Collect and maintain 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 (if applicable for region).
* 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 CA/EC.
*Responsible for the collection of critical documents required for IP Release.
* Attend study team meetings as required.
* 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.
* *Be familiar with ICH GCP, relevant country regulations/guidelines and ICON SOPs.
* Assist and provide support to the Study Start Up Lead to maximize submission effectiveness, minimize timelines and ensure sponsor satisfaction.
* Undertake other reasonably related duties as may be assigned from time to time
ICON 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 through the form below.