eGenesis - Senior Clinical Research Associate
Requirements
• Bachelor’s degree in life sciences, nursing, or related field required; advanced degree preferred • 4+ years of clinical monitoring experience in the pharmaceutical, biotechnology, or CRO industry • Experience managing academic medical center sites and supporting investigators or site teams with limited experience in industry-sponsored IND trials • Experience managing sites with high data volume and ensuring timely source documentation, CRF completion, and query resolution • Direct monitoring experience conducting all monitoring visit types including site qualification, site initiation, interim monitoring, and close-out visits • High preference for monitoring complex clinical trials involving critically ill or high-acuity patient populations (e.g., gene/cell therapy or transplant) • Strong knowledge of ICH-GCP guidelines, regulatory requirements, and clinical trial operations • Experience independently managing multiple investigative sites across the monitoring lifecycle and working in a cross-functional team environment • Strong organizational, communication, and problem-solving skills • Familiarity with eTMF, CTMS, and electronic data capture (EDC) systems • Team oriented and flexible; ability to respond quickly to shifting demands and opportunities • High attention to detail and commitment to quality • Ability to travel as required to conduct on-site monitoring visits • Base pay range for this job is $105,600-$158,400. • We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
Responsibilities
• 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
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