eGenesis, Inc.

Research Analyst

• Conduct site qualification, initiation, routine monitoring (on-site and remote), and closeout visits in accordance with the Clinical Monitoring Plan and study timelines
• Independently manage assigned investigative sites, including academic medical centers with limited IND experience, providing operational guidance to ensure protocol compliance, data quality, and effective management of high-volume clinical data
• Oversee clinical trial conduct at assigned sites to ensure protocol compliance, patient safety, data integrity, and accurate documentation
• Perform source data verification and review case report forms (CRFs) to ensure completeness, accuracy, and compliance with study requirements
• Prepare/finalize monitoring visit reports and follow-up communications within required timelines
• Train and support Principal Investigators and site staff on protocol procedures, regulatory requirements and GCP compliance
• Support site start-up and activation activities, including collection, review, and tracking of regulatory and essential documents
• Contribute to investigator selection and site feasibility assessments during study planning
• Partner with investigative sites to support patient recruitment and retention efforts and address enrollment barriers
• Monitor site performance and key study metrics (e.g., recruitment, data entry timelines, query resolution) to assess site performance and identify potential operational or compliance risks
• Evaluate site operational challenges, implement practical solutions to support site performance and study compliance, and escalate significant issues project leadership as appropriate
• Provide operational guidance and education to investigative site personnel, particularly at academic centers with limited IND experience, to support protocol implementation, regulatory compliance, and management of complex study procedures and data requirements
• Support risk-based monitoring activities by evaluating site performance indicators and identifying emerging operational or compliance risks
• Maintain accurate and timely documentation of monitoring activities and study records within the eTMF, CTMS, and other required tracking systems
• Collaborate with Clinical Operations and cross-functional teams to support effective study execution
• Support audit and regulatory inspection readiness, including participation in preparation activities and documentation review

Senior Clinical Research Associate

• Provide operational leadership and guidance to internal CRAs and oversight of external (CRO/vendor) CRAs to support study execution and ensure consistent monitoring practices, protocol compliance, and high-quality study execution across sites
• Serve as the primary point of contact for monitoring strategy alignment, issue escalation, identification and mitigation of site risks and operational challenges
• Author the Clinical Monitoring Plan (CMP) and develop study-specific monitoring tools, trackers, and guidance to support standardized monitoring practices and CRA oversight
• Review monitoring outputs and conduct oversight monitoring activities to ensure site compliance, data quality and adherence to the study protocols and plans
• Develop and deliver training materials and guidance for CRAs and study site personnel to support protocol compliance, monitoring consistency and effective study execution
• Track study startup activities, activation timelines, and site/study performance metrics; analyze trends to proactively identify risks and implement mitigation strategies to prevent or reduce operational impact
• Monitor site enrollment performance to identify potential operational challenges and implement mitigation strategies to maintain recruitment targets
• Investigate protocol deviations, monitoring findings, and site compliance issues, perform root cause analysis, and implement appropriate corrective and preventive actions (CAPA) in collaboration with the study team
• Ensure compliance with ICH-GCP, federal regulations, monitoring plans, and internal SOPs
• Maintain regulatory inspection readiness across study sites
• Ensure timely reporting and follow-up of safety events in collaboration with the study team

Lead Clinical Research Associate

Clinical Research

• Manage all aspects of clinical trials, including study vendor management, CRO oversight, timelines, and budgets
• Assist in preparation and review of clinical study documentation including, but not limited to, protocol, informed consent, Clinical Monitoring Plan, Project Plan, Case Report Forms, Clinical Study Reports, and other study level documents
• Engage cross-functionally to ensure clear, consistent communication to key stakeholders on study status, metrics and timelines
• Ensure implementation and conduct of study(ies) in accordance with SOPs and ICH-GCP guidelines
• Serve as point of contact for CRO and clinical site communication
• Set up the Trial Master File (TMF) and appropriately maintain the TMF throughout the trial, including periodic reviews
• Participate and coordinate resolution of audit findings and ensure audit-ready condition of clinical trial documentation including central clinical files
• Proactively identify risks in study timelines in regard to key milestones and deliverables and work closely with the cross-functional teams to mitigate downstream impacts

Senior Clinical Research Associate

Lead Clinical Research Associate

Senior Clinical Trial Manager