Clinical Research

• Serve as the primary point of contact between investigational sites and the sponsor
• Conduct site selection, initiation, routine monitoring, and close-out visits
• Ensure site compliance with ICH-GCP, SOPs, and regulations
• Maintain documentation in CTMS and eTMF systems
• Support and track site staff training and compliance records
• Monitor patient safety and ensure timely AE/SAE/PQC reporting
• Support subject recruitment and retention efforts
• Oversee drug accountability and proper storage, return, or destruction
• Resolve data queries and drive timely, high-quality data entry
• Document site progress and escalate risks or issues
• Assist with site budgets and payments as applicable
• Collaborate with CTAs, LTMs, and CTMs

Clinical Research Associate II

• Perform site management activities to support the client's Oncology site success and maintain a continuous state of inspection readiness
• Act as the primary contact and facilitate efficient communications between the client's clinical trial team and the sites
• Perform remote and on-site monitoring/co-monitoring visits, including Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits and Close-Out Visits, to ensure data integrity and subject safety
• Perform oversight activities to assess monitoring quality and train/mentor less experienced CRAs
• Document monitoring activities and submit/approve visit reports
• Manage site essential document collection and TMF reconciliation with site files
• Support sites with local IRB/EC submissions and confirm approvals
• Review site KRI metrics, issues and action items to detect trends and ensure prompt resolution
• Determine root causes and develop/implement site CAPA plans
• Deliver training to ensure sites comply with protocols, SOPs, GCPs and regulations
• Support sites and the client's regulatory inspections
• Contribute to site identification, drive site feasibility and qualification progress, and support site activation activities
• Lead site engagement initiatives and foster relationships with key Oncology sites and networks

Senior Clinical Research Associate

• Perform site management activities to support the client's Oncology site success and maintain continuous inspection readiness
• Act as primary contact and facilitate communications between the client's clinical trial team and sites
• Perform remote and on-site monitoring/co-monitoring visits, including Site Qualification, Site Initiation, Interim Monitoring, and Close-Out Visits
• Perform oversight activities to assess monitoring quality and train or mentor less experienced CRAs
• Document monitoring activities and submit or approve visit reports
• Manage site essential document collection and TMF reconciliation with site files
• Support sites with local IRB/EC submissions and confirm approvals
• Review site KRI metrics, issues, and action items to detect trends and ensure resolution
• Determine root causes and develop or implement site CAPA plans
• Deliver training on protocols, SOPs, GCPs, and regulations
• Support sites and the client’s regulatory inspections
• Contribute to site identification, feasibility, qualification, and activation activities
• Lead site engagement initiatives and foster relationships with Oncology sites and networks

• Manage investigator site relationships and assigned clinical trial sites
• Conduct site initiation, routine monitoring, remote/electronic monitoring, and site close-out activities
• Ensure clinical trials comply with monitoring plans, applicable laws, GCP, SOPs, and sponsor standards
• Serve as primary contact for assigned investigator sites and coordinate with study teams, vendors, and Site Care Partners
• Provide site personnel coaching, training, protocol training, and recruitment support
• Monitor adverse events and serious adverse events and collaborate with the Drug Safety Unit
• Submit Trial Master File documentation, site reports, follow-up letters, protocol deviations, recruitment updates, supply management records, study progress, and metrics
• Identify and resolve site issues, including corrective and preventive actions
• Resolve data queries and support database release
• Oversee investigational product receipt, handling, accounting, storage, and destruction
• Support patient safety, eligibility, clinical guidance, quality event remediation, audits, and CAPA activities
• May undertake unblinded monitor responsibilities where appropriate

Clinical Research Associate II/Senior Clinical Research Associate

• Manage one or more allocated Phase I through IV clinical trials, which may be local, regional, or global in scope
• Coordinate and manage clinical trials from start-up through closeout
• Direct the technical, financial, and operational aspects of projects
• Work with functional area leads to identify and evaluate project requirements
• Interpret data on complex issues
• Conduct contingency planning and implement rescue strategies when needed
• Ensure solutions are implemented
• Ensure project deliverables meet customer time, quality, cost, and contract expectations
• Lead core project team members and facilitate leadership of extended or complete project teams
• Lead internal and external cross-unit coordination, including subcontractors
• Define and manage project resource needs and establish contingency plans for key resources
• Ensure successful design, implementation, tracking, and revision of project plans
• Promote effective teamwork and resolve conflicts
• Ensure appropriate communication on project-related matters with CSM Management
• Work under the direct supervision and guidance of the Site Director; does not supervise other staff

Clinical Study Manager

• Manage the delivery of high-quality data from project start-up and planning through project execution and project closeout across several projects
• Independently perform project-specific quality control and quality assurance tasks
• Ensure consistency, accuracy, and adherence to federal regulations, Good Clinical Practice, Good Clinical Data Management Practices, SOPs, and Working Instructions
• Manage patient protocol information and incorporate protocol-specific guidelines into clinical trial data review
• Contribute to the design of databases and forms for clinical data entry and reporting
• Test new clinical trial data-management processes and systems
• Test clinical trial databases and data-entry screens for protocol and institutional compliance
• Process, track, and validate data accurately and on time
• Perform data abstraction and data entry across multiple clinical research databases and protocols
• Develop and extract patient clinical data reports for publications and presentations
• Use clinical databases and reporting tools
• Identify project-specific reports and assist in their development
• Prepare, review, and submit clinical data to monitoring agencies
• Maintain client communication on data-management project status and review key project questions

Clinical Data Manager – Level 2

• Oversee site management, monitoring oversight, and clinical trial operations activities
• Ensure compliance with GCP, regulatory requirements, and company SOPs
• Partner with Clinical Operations leadership to support clinical trial execution and monitoring activities
• Lead site feasibility, selection, initiation, and greenlight activities
• Develop and maintain study-specific operational plans, training materials, and monitoring documentation
• Oversee site engagement, regulatory submissions, and monitoring activities
• Review trial progress, patient recruitment, and data quality metrics, and implement actions to support study objectives
• Provide guidance and oversight to CRAs, including trip report review and training support
• Manage protocol and GCP deviations
• Contribute to continuous improvement of clinical operations processes and procedures
• Collaborate with cross-functional teams and clinical sites
• Travel domestically and internationally, up to 50%

Clinical Trial Manager

• Serve as the primary site-level contact for internal and external clinical-trial stakeholders
• Oversee the quality, integrity, and compliance of clinical trial sites
• Conduct site qualification, initiation, routine monitoring, and close-out visits across all trial phases
• Verify clinical-trial data in electronic systems and paper records for accessibility, completeness, and accuracy
• Monitor adherence to ICH GCP and local regulations, provide site training and support, and participate in audits and inspections
• Build relationships with cross-functional teams, vendors, clinical sites, and key stakeholders
• Motivate sites to meet enrollment and retention goals
• Prepare and submit monitoring and administrative reports
• Assess investigators and sites for resources and capabilities; identify potential investigators and sites
• Apply targeted, centralized, remote, and risk-based monitoring approaches
• Identify, prioritize, and mitigate site- and study-level risks
• Analyze site data and operational metrics and adjust monitoring strategies
• Perform unblinded site-monitor activities when applicable
• Review, reconcile, and oversee study drug/IMP
• Support regulatory compliance audits, inspections, corrective and preventive actions, and start-up/submission activities
• Support access to BMS and vendor systems and maintain internal systems for site monitoring
• Coordinate site activities related to database locks
• Perform timely site closure activities