Site Start-Up Specialist (SSU)
Site Start-Up Specialist (SSU)
我要購買
追蹤此職缺
投遞履歷
我要兌換
職缺說明
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:
- Serve as the primary point of contact for IRBs and other regulatory bodies throughout the site start-up process.
- Coordinate the preparation and submission of regulatory documents, including IRB applications, informed consent forms, and investigator brochures.
- Facilitate communication between study sponsors, investigative sites, and IRBs to ensure timely approval of study protocols and amendments.
- Conduct thorough reviews of IRB feedback and address any concerns or questions raised during the review process.
- Collaborate with cross-functional teams to develop and maintain site start-up timelines, tracking progress and addressing any delays or obstacles.
- Provide guidance to investigative site staff on IRB requirements, submission processes, and documentation standards.
- Ensure that all IRB-related activities comply with applicable regulations, guidelines, and company policies.
- Assist with the development and implementation of standardized processes and best practices for site start-up activities.
- Participate in site initiation visits and provide support as needed to ensure that sites are adequately prepared to begin enrolling subjects.
- Maintain accurate and up-to-date records of IRB submissions, approvals, and correspondence.
- Qualifications:
- Bachelor's degree in a scientific or healthcare-related field (Master's degree preferred).
- Minimum of 3 years of experience in clinical research, with a focus on site start-up activities and IRB submissions.
- In-depth knowledge of IRB regulations, guidelines, and processes, preferably in the context of pharmaceutical or biotechnology industry-sponsored trials.
- Strong organizational skills and attention to detail, with the ability to manage multiple tasks simultaneously and meet deadlines.
- Excellent communication and interpersonal skills, with the ability to effectively communicate with internal and external stakeholders.
- Proficiency in Microsoft Office applications and electronic document management systems.
- Ability to work independently with minimal supervision and as part of a team in a fast-paced environment.
- Willingness to travel occasionally for site visits and meetings, as needed.