Study Start Up Associate/Senior - Italy

Study Start Up Italy


Description

Position at Premier Research

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.

We’re looking for an exceptional Study Start-Up Associate II/Senior Study Start-Up Associate to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.

At Premier Research, we are science-minded and heart-centered. Join us.

The  Study Start-Up Associate performs country specific tasks associated with the start-up of a clinical trial in accordance with all applicable regulations, standards, and  study-specific requirements. This includes but is not limited to the following tasks: liaises with the Site Recruitment  Associate or Lead, as applicable, to provide site feasibility updates as well as study start-up metrics and site contact information for the site activation, coordinate with the Clinical Research Associate to disseminate the Investigator Site File binders, performs essential document collection and review, status tracking, site communications, Informed Consent review, Ethics Committees (ECs) /Institutional Review Board (IRB) and Regulatory Authorities (RAs) submissions and communications, protocol and other documents amendment management, submissions and follow-up to the appropriate governing authorities on a per country basis, site contract preparation and follow-up (ROW).

You'll be doing:
  • Takes responsibility for quality deliverables at the country level for study start-up
  • Prepares and submits Central EC/IRB Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required
  • Prepares ongoing submissions, amendments, and periodic notifications 
  • Performs and/or oversight of essential document collection and review
  • Be Local Investigator Contract and budget negotiator 
  • Works within the scope of Regulatory Start Up plan (RSSP), study processes
  • Provides training for local affiliate employees and other applicable internal teams 
  • May serve as an Independent Essential Document Reviewer and/or perform second pass review of Essential Documents
  • Assists with coaching, mentoring, supervising and training staff on the SSUA role. 
  • Participates in corporate initiatives and actions that ensure the continued success of the company
  • Participates in Client and/or internal Kick off meetings (KOM)
You need this to be considered:
  • Undergraduate degree or its international equivalent in a clinical, science
  • Min. 2 years professional experience as SSUA  in submission of clinical trial applications
  • Thorough knowledge of FDA Guidance Documents / EU Directives/Regulations / Local Regulations 
  • Good  knowledge of the relevant country specific regulatory requirements for conducting clinical trials
  • Fluency in English and local language
  • Maintains a positive, results orientated work environment
  • Excellent team player, collaborative and able to build an effective team
  • Excellent organizational and time-management skills, able to prioritize work to meet deadlines
  • Strong verbal and written communication and negotiation skills
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