Site Start up Associate II

Role: Site Start-up Associate II supporting clinical trial start-up activities within the Clinical Monitoring, Site Management, and SSU teams. Responsibilities: manage site initiation timelines, prepare and submit regulatory documents (EC/IRB, RA applications), review essential documents for compliance with ICH/GCP, negotiate site contracts and budgets, and review informed consent forms and patient documentation. Requirements: undergraduate degree in a health-related field or licensed healthcare professional; 3+ years of study start-up experience; strong knowledge of FDA, EU, local regulations, ISO14155, and clinical monitoring procedures; proficiency in regulatory submissions and contract negotiations; ability to work independently and meet deadlines. HighValue: clinical trial start-up, regulatory submissions, site contract negotiations, informed consent review, cross-regional compliance. WorkSetup: unspecified; compensation minimum $71,000 USD annually, with benefits.