Clinical Research

• Independently manage and monitor site activities for assigned clinical studies
• Conduct site qualification, site initiation, interim monitoring, and close-out visits
• Perform site evaluation visits and assess investigator-site capability
• Conduct study initiation activities, review protocols and regulatory issues, and train site personnel
• Maintain audit-ready Investigator Site Files and ensure timely document upload to the Trial Master File
• Communicate directly with investigational sites regarding visit planning, query resolution, action items, and site management
• Document clinical-trial-material accountability, stability, and storage conditions
• Perform investigational product inventory and coordinate return or destruction of unused materials
• Serve as primary site contact and coordinate correspondence and timely clinical-data transmission
• Perform study close-out visits, investigational-product reconciliation, site-file reconciliation, query resolution through database lock, and outstanding-action resolution
• Complete internal and study-related training within required timelines
• Complete pre- and post-visit follow-up, including confirmation letters, follow-up letters, and monitoring visit reports
• Collaborate with the CRA Line Manager on mentoring, training, and assessment of CRAs and junior staff as applicable
• Follow safety practices while traveling and visiting clinical research sites

Senior Clinical Research Associate – CRO Contract

• Independently manage and monitor site activities for assigned clinical studies
• Conduct site qualification, site initiation, interim monitoring, and close-out visits
• Ensure compliance with protocols, Lotus or Sponsor SOPs, FDA regulations, and ICH-GCP guidelines
• Perform site evaluation visits and assess investigators’ site capabilities
• Conduct study initiation activities, review protocols and regulatory issues, and train site personnel
• Ensure Investigator Site Files remain audit-ready and documents are uploaded to the Trial Master File
• Communicate with investigational sites regarding visit planning, query resolution, action items, and site management
• Document clinical trial material accountability, stability, and storage conditions; perform investigational product inventory
• Coordinate site correspondence and ensure timely transmission of clinical data
• Perform close-out visits, investigational product reconciliation and disposition, study file reconciliation, query resolution through database lock, and outstanding action-item resolution
• Complete internal and study-related training within required timelines
• Complete pre- and post-visit follow-up, including confirmation letters, follow-up letters, and monitoring visit reports
• Collaborate with the CRA Line Manager on mentoring, training, and assessment of CRAs and junior staff as applicable

Senior Clinical Research Associate – CRO-Contract

• Analyze large-scale, longitudinal data from electronic health records, laboratory and pharmacy databases, and patient-reported outcomes surveys
• Provide expertise on statistical design, data management, data quality control, and data analysis for observational and longitudinal research
• Participate as a coauthor on manuscripts and presentations reporting study results
• Use and expand SAS and R programs to clean and organize JHHCC and CNICS data
• Identify study-data problems and collaborate with data managers to resolve them
• Read concept sheets and draft statistical analysis plans
• Generate analytic datasets, codebooks, and documentation
• Analyze individual-level data to answer scientific questions
• Prepare tables and figures for publications and scientific meetings
• Contribute to technical/scientific writing and review concept sheets, reports, posters, and manuscripts
• Document study decisions and archive code for reproducibility
• Maintain a transparent shared research workspace
• Assist with research-proposal approach sections
• Attend meetings and provide project status updates
• Support statistical analysis plans and data collection tools such as CRFs
• Develop derived-dataset specifications and program derived datasets
• Develop and program table, listing, and figure shells and TLFs
• Program ad hoc analyses including sample-size calculations and data-missingness analyses
• Collaborate with project management to develop analysis timelines
• Perform other duties as assigned

Biostatistician, Neurology

• Oversee site-level execution of large, multicenter clinical trials across a national network of collaborating clinical sites
• Lead site startup, feasibility assessments, resource-readiness evaluations, activation timelines, and centralized IRB/master agreement onboarding
• Establish communication with clinical teams during identification, selection, preparation, and activation
• Drive enrollment performance, track site-level metrics, identify underperforming sites, and develop customized remediation strategies
• Manage investigator and site relationships; set expectations, assign deliverables, and hold sites accountable
• Direct and monitor daily activities involving eligibility, randomization, protocol adherence, safety reporting, and investigational-product compliance
• Ensure timely and accurate submissions to IRBs, sponsors, ethics committees, and master agreements
• Conduct teleconferences, training broadcasts, and mentoring for coordinators and investigators
• Provide support to quality assurance monitors
• Manage site startup and performance plans, quality reviews, resource needs, escalations, and deadlines
• Apply lean management processes to deliver trials on time, within budget, and to high-quality standards
• Perform self-audits and site audits; recommend operational and protocol improvements
• Track proposals and documentation through signature and approval processes
• Use statistical, quantitative, explanatory, and predictive analysis to drive decisions
• Help investigators interpret performance-based data
• Facilitate meetings between project stakeholders and leadership
• Maintain professional project documentation and deliverables
• Develop SOPs and assist with study-site auditing and monitoring
• Maintain knowledge of evolving clinical research technology and support innovation adoption
• Serve as liaison between leadership and research communities
• Perform other duties as assigned

Clinical Research Site Manager, Neurology

• Oversee site-level execution of large, multicenter clinical trials across a national network of collaborating clinical sites
• Coordinate teams at other institutions and establish communication with clinical teams during identification, selection, preparation, and activation
• Lead site start-up activities, feasibility assessments, resource-readiness evaluations, activation timelines, centralized IRB onboarding, and master-agreement processes
• Drive enrollment performance and monitor monthly enrollment goals across clinical sites
• Assist with IRB, sponsor, ethics committee, regulatory-document, contracting, and compliance processes
• Oversee investigational-product compliance, safety-event reporting, subject eligibility, randomization, and protocol adherence
• Identify recruitment problems and design customized remediation strategies with site teams
• Conduct teleconferences, manage training broadcasts, and mentor coordinators and investigators
• Manage investigator relationships, assign site tasks and deadlines, monitor daily site work, and escalate quality, functional, and timeline issues
• Apply lean management processes to deliver trials on time, within budget, and to high-quality standards
• Perform self-audits and clinical-site performance audits; recommend operational or protocol improvements
• Track proposals and documentation through signature and approval processes
• Use statistical and quantitative analysis, explanatory and predictive modeling, and fact-based management to drive decisions
• Serve as liaison among project stakeholders, leadership, and research communities
• Complete project documentation, develop SOPs, and assist with study-site auditing and monitoring
• Maintain strong relationships and support adoption of evolving clinical research technologies