Study Start-Up Specialist/Site Activation Partner - FSP
On-siteRemote, Oregon, United States
Job Summary
Lead or support operational activities from start-up to close-out for assigned studies and investigator sites to ensure compliance with study timelines, Good Clinical Practices, and sponsor standards. Initiate and coordinate activities and essential documents management towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for site initiation. Provide support to resolve issues or concerns and timely escalation of Site issues where applicable. Manage and coordinate with other supporting roles to ensure timely site activation and operational activities. Collaborate with in country regulatory group, provide related/applicable site documents, and update clinical trial systems that track site compliance and performance within project timelines. Parexel is a leading global clinical research organization providing insights-driven Clinical and Consulting solutions to the world's life sciences industry.
Required Qualifications
- School diploma/certificate with equivalent combination of education, training and experience
- BS/BA or bachelor's degree in life sciences
- Minimum 2 years relevant experience in Clinical Trials environment and clinical site activation
- Knowledge of clinical trial methodologies
- Knowledge of ICH/GCP
- Knowledge of FDA and Global and local country regulations
- Fluency in Local language
- Fluency in English
Desired Qualifications
- Experience working in the pharmaceutical industry/or CRO
- Multi-language capability
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