CTI Clinical Trial and Consulting Services

Clinical Research

• Serve as the main CTI contact for assigned study sites
• Conduct pre-study, site initiation, interim monitoring, and close-out site visits
• Complete site visit deliverables according to the Monitoring Plan and required timelines
• Assist with or oversee study start-up, feasibility, pre-study activities, and site selection
• Collect, review, and track essential and regulatory documents
• Participate in required training and investigator, client, and project team meetings
• Create and implement subject enrollment strategies for assigned sites
• Ensure proper storage, dispensation, and accountability of investigational product and trial-related materials
• Perform site management activities and provide site status updates to the Clinical Project Manager
• Conduct remote monitoring according to the study-specific Monitoring Plan
• Use systems and reports to track subject status, CRF retrieval/source document review, regulatory documents, and investigational product
• Assist with project-specific activities as a Project Team member

Senior Clinical Research Associate II – UK

Compliance

• Manage essential regulatory documentation for clinical studies throughout the study lifecycle
• Assist and advise project teams on regulatory requirements
• Perform compliance assessments and notify Project Managers of findings
• Review and adapt study-specific documents for country and site requirements
• Perform IRB/EC/CA submissions on behalf of sponsors and/or sites
• Receive, process, and quality-check study documentation from sites
• Coordinate with site personnel, CPCs, CRAs, PMs, sponsors, and CTI management to resolve documentation issues
• Compile regulatory documentation and timelines and perform QC reviews before submission
• Assist with and adapt site-specific Informed Consent Forms
• Forward regulatory documentation and final submission packages to sponsors as requested
• Assist with responses to contingency letters from IRB/IEC/CA
• Compile and assess regulatory packages for drug release
• Provide periodic regulatory status reports and attend internal and external project meetings
• Apply naming conventions and upload/process documentation in study-startup modules, trackers, and TMF systems
• Maintain site documentation throughout the trial
• Perform review, reconciliation, close-out, and archiving activities
• Assist with sponsor or agency audits and inspections
• Assist with QC and QA of regulatory documents and reports
• Oversee translation of regulatory documents when needed
• Attend study meetings and provide regulatory status reports for each site and country

Regulatory Affairs Study Start Up Specialist

• Serve as the main CTI contact for assigned study sites
• Conduct pre-study, site initiation, interim monitoring, and close-out visits
• Complete site visit deliverables according to monitoring plans, timelines, regulatory requirements, SOPs, and ICH GCP
• Assist with study start-up, feasibility, pre-study activities, and site selection
• Collect, review, and track essential and regulatory documents
• Complete required general and study-specific training
• Participate in investigator, client, and project team meetings, including presentations
• Create and implement subject enrollment strategies
• Ensure proper storage, dispensation, and accountability of investigational products and trial materials
• Perform site management activities and provide site-status updates to the Clinical Project Manager
• Conduct remote monitoring according to study-specific monitoring plans
• Track subject status, CRF retrieval/source document verification, regulatory documents, and investigational products using systems and reports
• Support project-specific activities as a Project Team member
• Participate in developing CRFs and other study-related documents
• Translate, customize, and review patient information sheets, informed consent forms, protocol synopses, and other applicable documents
• Support Regulatory Affairs Study Start-up with submissions to ethics committees, regulatory authorities, competent authorities, and institutional boards where applicable
• Provide regular updates to sponsors/clients
• Support site contract negotiations, investigator payments, and site-payment tracking where applicable
• Manage investigator site files and trial master files for assigned sites
• Identify and anticipate site issues, implement corrective actions, or escalate as appropriate
• Liaise with Clinical Data Management on data-cleaning activities
• Mentor and train CRAs, including conducting training/assessment visits
• Function as Lead CRA for assigned projects

Clinical Research Associate II

Business Development Rep

• Sell CTI clinical trial, regulatory and scientific affairs consulting services
• Sell Phase I–III clinical trials and regulatory consulting services from pre-IND to NDA support
• Identify, contact and cultivate new clients
• Serve as client manager for existing clients
• Secure and maintain relationships with qualified targets and decision makers in biotech and pharma
• Uncover sales opportunities and develop sales strategies
• Develop targeted business development accounts and align CTI offerings with customer needs
• Collaborate with the proposal team to deliver budgets and proposals
• Provide direction on proposal text and budget scope
• Develop relationships with clinical operational management and proposal/contracting teams
• Develop and implement disease strategies for awareness, lead generation and opportunity identification
• Represent CTI at therapeutically focused conferences and meet prospective clients
• Lead and participate in bid defense and capabilities discussions
• Communicate with accounts and internal representatives to ensure account needs are met
• Present sales opportunities to management and collaborate internally to close complex sales
• Monitor and update lead status to maintain the sales pipeline
• Communicate account activity to sales leaders and CTI executives
• Maintain CRM updates
• Manage sales departmental metrics

Director, Business Development – Client Management

Director

• Lead development, management and oversight of the trial site budgets team
• Serve as a high-level operational contact with leadership
• Coordinate standardization and best practices for CTI site budget development processes
• Provide operational direction, prioritization, coaching, performance management and ongoing optimization
• Ensure team deliverables meet timelines, quality standards and business requirements
• Identify risks, capacity constraints, bottlenecks and milestones and implement corrective actions
• Ensure budgets align with study, sponsor, regulatory and organizational requirements
• Simplify, standardize, automate and optimize workflows with Site Activation and cross-functional teams
• Establish and maintain standardized budget processes, tools, templates and operating procedures
• Monitor operational data and trends and provide actionable insights to senior leaders
• Lead resolution and escalation of complex or high-risk budget issues
• Drive adoption of organizational change, processes, systems and ways of working
• Share lessons learned with the Site Activation team and improve budget processes
• Plan, implement, facilitate and evaluate assigned clinical trials from planning through analysis
• Serve as primary senior interface with CTI executive management and sponsors
• Manage client relationships and resolve or escalate trial issues
• Ensure compliance with ICH, GCP, regulatory guidelines and trial procedures
• Oversee CPM management of budgeted hours, project budgets, milestones and corrective measures
• Review scope of work against contractual agreements and assist with scope changes and contract amendments
• Supervise, mentor and evaluate CPMs and direct reports
• Oversee recruitment, resourcing and management of site budget/payment specialists
• Establish training programs for site budget and payment services staff
• Provide high-level review and oversight of site budget development for RFPs

Associate Director, Site Budgets

• Direct CDM team activities to complete project deliverables on schedule, within quality standards, requirements, and budget from study start-up through archival
• Serve as CTI CDM representative on project teams
• Recommend work-process improvements and respond to questions about CDM processes, timelines, and data quality
• Maintain relationships with internal customers and sponsors, providing project updates and coordinated plans
• Establish CDM deliverables, time estimates, data-cleaning guidelines, conventions, GSOPs, workflows, and related processes
• Monitor timelines, enrollment, data collection, quality, GSOP compliance, workflow, and project budgets
• Identify out-of-scope activities and manage sponsor or management approvals and cost documentation
• Provide or arrange project-specific training and mentor lower-level Clinical Data Managers
• Develop accurate project reports for sponsors, project teams, and CTI management
• Coordinate receipt, handling, and reconciliation of external data sources including central laboratory, ECG, and serious adverse events data
• Prepare for and participate in meetings, complete action items, and provide input
• Maintain study documentation and CDM project plans reflecting deviations and scope changes
• Conduct post-mortem analyses and provide study metrics to CDM management

Senior Clinical Data Manager

• Develop and execute strategic territory plans to prioritize, pursue, and convert competitive customer accounts and leads
• Create in-depth prospect profiles and present available services to primary decision makers, including reviewing in-house versus outsourced testing
• Develop customer relationships with key business executives and stakeholders and prepare sales reports
• Represent laboratory services including assay development, safety testing, specimen and specimen kit management, biorepository, bioanalytical, and specialty testing
• Lead the business development process from due diligence and early engagement meetings through the RFP process and closing opportunities
• Collaborate with CTI internal staff on proposal development and procurement
• Work with Marketing, Business Development, Medical Affairs, and other teams to identify targeted therapeutic, disease, and product-specific opportunities
• Participate in client bid defenses
• Answer client inquiries, identify improvement areas, and identify new business opportunities among existing customers
• Support new accounts during onboarding to ensure a high level of client service
• Maintain a sufficient opportunity pipeline to achieve the annual sales goal
• Attend client meetings to monitor service, provide direction and feedback, and assess performance
• Support marketing initiatives, including tradeshows and symposium attendance
• Help establish the overall North American yearly Lab Services Sales Target
• Recruit and hire BD Lab Services Sales team members
• Help establish individual sales targets for Lab Services Sales team members
• Schedule and attend weekly meetings with BD Sales Team members to monitor sales activities and opportunities
• Attend regularly scheduled meetings at CTI Global Corporate HQ in Covington, Kentucky, including quarterly BD meetings
• Monitor monthly time and activity versus productivity of the BD Sales Team to assess and implement continuous improvement