Lexitas

Research Analyst

• Oversee and review site activities for clinical trials
• Monitor trial records for subject protection and data verifiability
• Perform pre-study, initiation, interim monitoring and close out visits
• Manage all aspects of a clinical study
• Provide technical, scientific, and operational guidance to site personnel
• Track and report enrollment and identify issues
• Coordinate the collection and approval of essential and regulatory documents
• Assist team members with site-specific issues and mentor junior CRAs

Clinical Research Associate II

Clinical Operations

• Provides support to Study Management and other study team members
• Responsible for in-house site management
• Manages all protocol-level and investigator-related clinical trial documents, study supplies, and vendor information
• Keeps study-related essential documentation current and filed
• Facilitates collection and review of essential documents, budgets/contracts, and IRB documentation on behalf of sponsor and site.

Clinical Operations Specialist

Director

• Managing all contracts and proposals staff
• Owning of all contracts and proposals processes
• Owning all contracts and proposals data and tools including the budget calculator
• Oversee the production of all proposals and clinical contracts including budgets throughout the project lifecycle; owning deliverables as needed
• Participating in senior leadership meetings and associated initiatives.
• Leading the RFP response process in all stages, including coordination with partners/vendors, internal team review meetings, development of proposal strategy and management of process and all associated requests.
• Serve as primary contact for the internal team during contract preparation / amendment.
• Managing deliverable schedules and managing multiple deadlines with tight timelines.
• Collaborating with subject matter experts to understand the processes, business needs, and other contextual details to elicit the appropriate information needed to compose high-quality proposals.
• Support the sales function with proposals, contracts and reporting.
• Support hiring and training of new team members as needed.​
• Procure approved vendor budgets for pending proposals.
• Ensure accurate entry of proposal and contracts data in salesforce.com​.
• Support project teams during contract negotiations (internal and external discussions).

Clinical Research Associate II

Clinical Operations Specialist

Associate Director – Proposals and Contracts