Global Study Start-Up Associate

The Global Study Start-Up Associate manages the coordination, preparation and review of clinical regulatory documents including tracking and reporting of key performance by site and by study. The Global Study Start-Up Associate prepares and/or reviews submissions for clinical studies to local or central IRB/EC and Regulatory Authorities, as appropriate, in an ongoing manner maintaining compliance with local state/province or country laws and regulations. The Global Study Start-Up Associate brings regulatory, timeline or other concerns to the attention of the Global Study Start-Up Lead and/or Project Team and actively participates in finding solutions. The Global Study Start-Up Associate maintains awareness of local/country agency changes in regulations and forms.

• Prepares (when applicable) and disseminates regulatory essential document packages to sites.
• Complete review of essential documents following RDQC (Regulatory Document QC).
• Prepare, compile and submit CTAs to Regulatory Authorities and Central IRB/EC (if applicable).
  • Including but not limited to communication with regulatory authorities and/or central ethics committees regarding submission strategy and follow up on ongoing submissions under review.
• Complete review of CTAs prior to submission to Regulatory Authorities and IRB/EC as part of internal QC process.
• Assists GSSU Lead in coordinating efforts for all site activation related activities including but not limited to obtaining and maintaining regulatory and ethics approvals, review and approval of essential documents for RDQC/IP Release
• Prepares ongoing submissions, amendments, and periodic notifications required by central and local IRB/EC, RA, and other local regulatory authorities as needed within the country. Including safety notifications as required by local laws/guidelines, with minimal oversight.
• Responsible for tracking of overall study site status
  • Site status and regulatory documentation (including but not limited to RA and IRB/EC submission, meeting dates, approval status/date, and expiration dates as well as other regulatory documents as required).
• Customize country/site specific Patient Information Sheet and Informed Consent Forms.
• Ensure all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements.
• Maintain timelines for site start-up
• Identify site issues (risks) during start-up process; resolve minor to moderate issues independently; escalate and participate in the resolution of complex issues.
• Escalate risks (e.g. timelines, etc.) to GSSU Lead or PM, as appropriate
• Participates in conference calls and provide necessary Regulatory updates to Study Team and/or Sponsor, as required.
• Facilitates translation of site level documents as required.
• Review translations of regulatory documents, as applicable.
• Provide regular local status updates to SSU Project Lead or PM (as applicable); update appropriate study-tracking tools with local essential document and ethics committee status, and maintain project tracking systems for assigned projects.
• Support the development of start-up plans and essential document checklists.
• Act as GSSU Lead on projects with limited scope establishing the CTA submission strategy (Regulatory Authorities and IRB/EC).
• Maintain proficiency of local requirements for documentation of IRB/EC and Regulatory Authority submission approvals, and subsequent follow-up documentation and providing updates of local processes and requirements to the Regulatory Intelligence portal
• Provide advice and guidance to internal and external team members to ensure compliance with applicable regulations and requirements
• Act as Subject Matter Expert (SME) in a specific project, region or country
• Review pertinent regulations and guidance to develop proactive solutions to regulatory submissions issues and challenges
• Facilitates, or assists GSSU Lead (as applicable) with, the registration of and maintenance of ongoing updates for clinicaltrials.gov, if task delegated to Advanced Clinical by Sponsor.
• Occasional travel may be required

• Bachelor's Degree (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or relevant clinical other equivalent experience

• 1-2 years experience in a clinical research environment with basic knowledge of clinical processes and documentation
• Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of information
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Strong organizational skills
• Ability to effectively interact with project team(s) and effectively communicate in English and the local language of the country where located
• Ability to work independently in a fast-paced environment with a sense of urgency to match the pace
• Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade