Clinical Site Start-up & Regulatory Specialist

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Job description

About this role:

The Sr. Site Start-up and Regulatory Document Specialist supports the Global Clinical Operations Center of Excellence, conducting activities consistent with the mission of Global Clinical Operations to inform, connect and advance the company’s Global Clinical Organization. Through coordination with the Business Unit Liaison, and collaboration with divisional and regional clinical teams, the Document Management Analyst conducts clinical trial site start-up activities related to the preparation and approval of regulatory documents, ensuring they are carried out consistent with service level agreements, legal and regulatory standards, and applicable company policies and procedures.  Specifically, these activities will include Competent Authority (CA) & Ethics Committee (EC) submissions and approvals, Site informed consent form (ICF) customizations & negotiations, essential regulatory document collection, and other site start up support activities, as applicable.


Your responsibilities will include:

  • Work independently and proactively to coordinate all necessary activities for site regulatory submissions and essential document collection for allocated clinical research sites
  • Manage multiple sets of essential regulatory documents across several studies and division portfolios.
  • Partner with clinical sites to support the negotiation and customization of Informed Consent Form (ICF)
  • Develop and foster clinical research site relationships to become a subject matter expert in the site start up regulatory process across multiple studies
  • Leverage knowledge of site regulatory processes and division priorities to meet clinical study goals and objectives
  • Manage to achieve target IRB/EC timelines by assisting clinical research sites with the application submission process and approval tracking
  • Manage and problem solve site start up challenges that arise to mitigate impact to service level agreement and study goals
  • Develop, prepare, complete and track required regulatory, ICF and legal documentation.
  • Document clinical research site and investigator readiness for participation across multiple studies
  • Support internal quality audits, regulatory inspections, as applicable
  • Update and maintain study-specific startup trackers
  • Update and maintain site specific startup metrics in Clinical Trial Management Systems File and maintain site start up documents in eTMFs
  • Provide updates to leadership on site start up activities, investigator readiness, regulatory submission and approval status, etc.
  • Escalate challenges and/or initiate outreach to Principal investigators, clinical research site coordinator, divisional clinical study leads and/or other stakeholders when appropriate
  • Ensure compliance with appropriate regulatory (ICH/GCP, CA, EC, etc.) and internal SOPs/WI, policies & procedures


Education, Qualifications and Experience:

  • Bachelor’s Degree, or an equivalent combination of experience and education
  • 4+ years’ experience in clinical/scientific research and medical device experience, specifically clinical study site start-up experience within assigned geographies
  • Demonstrated ability to establish credibility internally and externally by commanding knowledge of informed consent requirements
  • Experience working with investigational review boards
  • Experience working with clinical trial management systems (e.g. Siebel CTMS, Veeva) and clinical document control systems / eTMF
  • Ability to multi-task: support several studies and/or personnel simultaneously, work in a very fast-paced environment
  • Ability to work in a team environment and possess clear, concise communication & presentation skills – written and verbal
  • Must be comfortable interacting with clinical research site personnel via phone, email, and in person



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