Study Start Up Associate II
TA Business Partner
About the role
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- 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:
- 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
- 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
- Due to the nature of this position it may be required for the employee to travel. Therefore, dependent on the employee’s location, the employee may be required to possess a valid Driver’s license
Application process
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