Primary contact and liaison with investigative sites during study maintenance and -when assigned-, site start-up (SSU) activities, with responsibility for collection of the required investigator and regulatory documents to ensure EC applications are made within the timelines agreed with project management and SU team Collect, track and perform a quality review of all essential & investigator documents required for effective and compliant study site activation and maintenance Ensure that all assigned maintenance and Start-up activities are on track and in accordance with client expectations, ICH/GCP, SOPs, budget, quality and applicable laws and guidelines Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner. With guidance from line manager and experienced colleagues, adapt Informed Consent Forms and other patient facing material to country specific requirements. May support / assist the contract negotiation process
University/College degree (life science preferred), or certification in related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology)
Minimum 0 – 2 + years of experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines. Demonstrated basic understanding of the clinical trial process
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