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Study Start Up Associate I

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About the role

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Study Start Up Associate
 
The Study Start Up Associate is responsible for the preparation and approval of country related submission packages in accordance with ICH, GCP and all applicable regulations, laws and other guidelines and ethical standards – within specific timelines and quality standards.  Also responsible for the 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.
 
Job Functions and Responsibility
 
 
  • 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.
 
  • 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.
 
  • Travel (approximately 5%) domestic and/or international.  Anticipated activities may include attendance at Kick-Off, Investigator or study team meetings.
 
 
Experience Skills and Knowledge Required
 
  • Prior relevant experience and/or understanding of clinical study start up requirements and activities.
  • Good organizational skills and the ability to manage multiple tasks.
  • An excellent level and proven experience of high standards of attention to detail.
  • Good written and verbal communication skills.  Proficient in English and language required for country assignments.
  • Ability to be customer focused is essential.
  • Logical and critical thinking skills.
  • 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.
Education Requirements
High School diploma, or local equivalent, required.  Bachelors degree, or local equivalent, preferred.
 *LI-AC1
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