Clinical Research

• Perform feasibility studies for potential sites
• Conduct pre-study, study initiation, interim monitoring, site management, and study close-out visits
• Function as Lead CRA for global studies and coordinate CRAs
• Develop Clinical Monitoring Plans
• Review site visit trip reports and provide feedback
• Mentor and guide less experienced CRAs and site staff
• Design study-specific tools and templates
• Participate in study team, investigator, and bid defense meetings
• Create and conduct training for study team members or colleagues
• Work with Project Management to evaluate deliverables and study milestones
• Compile regulatory and ethical submission documentation
• Coordinate shipment and receipt of study materials
• Document site visit findings in written reports
• Provide input into protocols and CRFs
• Assess, monitor, and train site staff on protocol adherence
• Review subject safety information and informed consent
• Conduct source document verification
• Review CRFs in paper or electronic data capture systems and assist with data query resolution
• Assist sites with Investigator Site File maintenance
• Maintain regular communication with sites
• Update site-related documentation for Trial Master File filing
• Ensure site compliance with investigational product receipt, accountability, and return or destruction
• Conduct accompanied site visits for CRA assessment or training
• Complete final site close-out visits and reports
• Perform other duties as assigned

Senior Clinical Research Associate – CVM/IMID

• Oversee clinical trial management workstreams, ensuring deliverables meet quality and timeline expectations
• Collaborate with cross-functional teams to design and implement effective clinical trial enrollment
• Develop and implement comprehensive clinical trial protocols with cross-functional teams
• Oversee and manage day-to-day clinical trial operations
• Ensure compliance with regulatory standards
• Analyze and interpret clinical trial data, identify trends, and provide insights to optimize study outcomes
• Proactively address challenges and implement effective solutions
• Communicate with internal and external stakeholders to foster partnerships and facilitate smooth trial processes
• Develop the team and manage competing priorities

Clinical Trial Manager

• Perform monitoring and site management work to ensure study sites conduct studies and report data according to protocol, regulations, guidelines, and sponsor requirements
• Perform site monitoring visits, including selection, initiation, monitoring, and close-out visits
• Drive and track subject recruitment plans
• Administer protocol and study training to assigned sites
• Establish regular communication with sites to manage project expectations and issues
• Evaluate study-site quality and integrity and escalate quality issues
• Track regulatory submissions and approvals, recruitment and enrollment, CRF completion and submission, and data query generation and resolution
• Support the study start-up phase where applicable
• Ensure site documents are available for Trial Master File filing and verify Investigator's Site File maintenance
• Document site management activities, monitoring findings, and action plans through visit reports and follow-up letters
• Collaborate with study team members to support project execution
• Support development of project subject recruitment plans on a per-site basis where applicable
• Support site financial management and retrieve invoices according to local requirements where applicable