Site Start-Up Specialist (SSU)

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Site Start-Up Specialist (SSU)
 
  • Summary:
We are assisting our clients in the pharmaceutical and clinical industry in their search for a detail-oriented and experienced Site Start-Up Specialist with a focus on Institutional Review Board (IRB) processes. The SSU Specialist will be instrumental in initiating and coordinating activities associated with the start-up of clinical trial sites, emphasizing proficiency in navigating IRB requirements and ensuring adherence to regulatory standards. The ideal candidate will possess a minimum of 3 years of experience in IRB-related activities and a comprehensive understanding of clinical trial start-up procedures.
 
  • Responsibilities:
  1. Serve as the primary point of contact for IRBs and other regulatory bodies throughout the site start-up process.
  2. Coordinate the preparation and submission of regulatory documents, including IRB applications, informed consent forms, and investigator brochures.
  3. Facilitate communication between study sponsors, investigative sites, and IRBs to ensure timely approval of study protocols and amendments.
  4. Conduct thorough reviews of IRB feedback and address any concerns or questions raised during the review process.
  5. Collaborate with cross-functional teams to develop and maintain site start-up timelines, tracking progress and addressing any delays or obstacles.
  6. Provide guidance to investigative site staff on IRB requirements, submission processes, and documentation standards.
  7. Ensure that all IRB-related activities comply with applicable regulations, guidelines, and company policies.
  8. Assist with the development and implementation of standardized processes and best practices for site start-up activities.
  9. Participate in site initiation visits and provide support as needed to ensure that sites are adequately prepared to begin enrolling subjects.
  10. Maintain accurate and up-to-date records of IRB submissions, approvals, and correspondence.
  • Qualifications:
  1. Bachelor's degree in a scientific or healthcare-related field (Master's degree preferred).
  2. Minimum of 3 years of experience in clinical research, with a focus on site start-up activities and IRB submissions.
  3. In-depth knowledge of IRB regulations, guidelines, and processes, preferably in the context of pharmaceutical or biotechnology industry-sponsored trials.
  4. Strong organizational skills and attention to detail, with the ability to manage multiple tasks simultaneously and meet deadlines.
  5. Excellent communication and interpersonal skills, with the ability to effectively communicate with internal and external stakeholders.
  6. Proficiency in Microsoft Office applications and electronic document management systems.
  7. Ability to work independently with minimal supervision and as part of a team in a fast-paced environment.
  8. Willingness to travel occasionally for site visits and meetings, as needed.
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