Leading mid-size CRO working in biologics, device and medical cannabis.
•Clinical Operations (Clinical Leads, Senior CRAs, Project Management, Clinical Study Assistants)
•Clinical Monitoring
•Medical Writing
•Study Start-Up Activities
•Drug Safety
•Clinical Quality Auditors
•Clinical Site Management Operations
•Clinical SOP Development, Training and Implementation
•Merger and Acquisition Due Diligence, C-Level Executive Strategic Consulting
•SOX Compliance Adherence & Preparation for Sponsors to go public
•Site fiscal compliance & the National Coverage Decision; the impact on Sponsor timelines, budgets & site agreements
•Global SMO/Site Agreement, Investigator Initiated Study Negotiations, Management and Payment Services
•Investigator Initiated/Sponsored Study Budgets & Contracts
•Medicare Coverage Analysis and National Coverage Decision analysis
•Global Outsourcing and Procurement Negotiations, Management and Payment Services, Service Provider Relationship Management/Governance and Functional Leadership
•Development of SOP/Processes for Outsourcing and Site Contracting
•Staff Recruitment
•Meeting Planning Services

Affinity Bio Partners, LLC

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