Study Start Up Associate I

Study Start Up Associate II

Seoul, Korea

This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. As a SSU you will be responsible for the independent preparation, review and approval of country related submission packages in accordance with ICH, GCP and all applicable regulations, laws and other guidelines and ethical standards Also responsible for the independent preparation, review and approval of site level critical documents for Investigational Product (IP) release in accordance with regulatory/sponsor requirements – within specific timelines and quality standards.  Developing and finalizing Master and Country Specific Information Sheets/Informed Consent Forms (SIS/ICFs)

Overview of the role

• 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 15%) 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 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:a
• 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
• Review and translate Drug Labels
• Advise Sponsor on knowledge content for development of Drug Labels
• Perform independent quality review of submission package
• Responsible for the collection and maintenance of 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 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 

Role Requirements  

• Bachelor’s Degree or local equivalent and/or appropriate experience from the Medical/science background and/or discipline
• At least 2 year of previous relevant experience in Study Start Up area
• Experience and/or understanding of clinical study start up requirements and activities
• An excellent level and proven experience high standards of attention to detail
• Good command of written and spoken English
• Competent computer skills