Senior Clinical Research Associate

About eGenesis eGenesis is a clinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Company’s proprietary genome engineering platform enables extensive, multiplex gene edits to remove key biological barriers, add protective human transgenes, and inactivate endogenous retroviruses. EGEN-2784, a genetically engineered porcine kidney, is the Company’s lead program and is currently being evaluated in a multi-patient Expanded Access study at MGH. eGenesis is headquartered in Cambridge, MA. eGenesis is seeking a Senior Clinical Research Associate with 4+ years of experience monitoring complex clinical trials in pharmaceutical, biotechnology, and CRO environments. Demonstrated experience in independently managing investigative sites and conducting site qualification, initiation, routine monitoring (on-site and remote), and closeout visits, while ensuring compliance with ICH-GCP, regulatory requirements, and study protocols. Proven ability to oversee site performance, maintain data integrity through source data verification and CRF review, and ensure timely documentation in eTMF, CTMS, and EDC systems. Skilled in supporting site start-up, training investigators and site staff, and providing operational guidance to academic medical centers and sites with limited IND experience. The ideal person for this role is experienced in identifying operational risks, implementing mitigation strategies, and managing high volume clinical data to maintain patient safety and data quality and study compliance. You will work under the guidance of the Lead CRA or Clinical Operations leadership to execute monitoring strategies and ensure consistent oversight of assigned sites. We are looking for a collaborative team member who works closely with investigative sites and cross-functional teams to support enrollment, resolve operational challenges and maintain inspection readiness. PRIMARY 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 QUALIFICATIONS 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.

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      "text": "PRIMARY RESPONSIBILITIES",
      "content": "<div>\n\n<li>Conduct site qualification, initiation, routine monitoring (on-site and remote), and closeout visits in accordance with the Clinical Monitoring Plan and study timelines</li>\n<li>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</li>\n<li>Oversee clinical trial conduct at assigned sites to ensure protocol compliance, patient safety, data integrity, and accurate documentation</li>\n<li>Perform source data verification and review case report forms (CRFs) to ensure completeness, accuracy, and compliance with study requirements</li>\n<li>Prepare/finalize monitoring visit reports and follow-up communications within required timelines</li>\n<li>Train and support Principal Investigators and site staff on protocol procedures, regulatory requirements and GCP compliance</li>\n<li>Support site start-up and activation activities, including collection, review, and tracking of regulatory and essential documents</li>\n<li>Contribute to investigator selection and site feasibility assessments during study planning</li>\n<li>Partner with investigative sites to support patient recruitment and retention efforts and address enrollment barriers</li>\n<li>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</li>\n<li>Evaluate site operational challenges, implement practical solutions to support site performance and study compliance, and escalate significant issues project leadership as appropriate</li>\n<li>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</li>\n<li>Support risk-based monitoring activities by evaluating site performance indicators and identifying emerging operational or compliance risks</li>\n<li>Maintain accurate and timely documentation of monitoring activities and study records within the eTMF, CTMS, and other required tracking systems</li>\n<li>Collaborate with Clinical Operations and cross-functional teams to support effective study execution</li>\n<li>Support audit and regulatory inspection readiness, including participation in preparation activities and documentation review</li>\n\n</div>"
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      "content": "<div>\n\n<li>Bachelor’s degree in life sciences, nursing, or related field required; advanced degree preferred</li>\n<li>4+ years of clinical monitoring experience in the pharmaceutical, biotechnology, or CRO industry</li>\n<li>Experience managing academic medical center sites and supporting investigators or site teams with limited experience in industry-sponsored IND trials</li>\n<li>Experience managing sites with high data volume and ensuring timely source documentation, CRF completion, and query resolution</li>\n<li>Direct monitoring experience conducting all monitoring visit types including site qualification, site initiation, interim monitoring, and close-out visits</li>\n<li>High preference for monitoring complex clinical trials involving critically ill or high-acuity patient populations (e.g., gene/cell therapy or transplant)</li>\n<li>Strong knowledge of ICH-GCP guidelines, regulatory requirements, and clinical trial operations</li>\n<li>Experience independently managing multiple investigative sites across the monitoring lifecycle and working in a cross-functional team environment</li>\n<li>Strong organizational, communication, and problem-solving skills</li>\n<li>Familiarity with eTMF, CTMS, and electronic data capture (EDC) systems</li>\n<li>Team oriented and flexible; ability to respond quickly to shifting demands and opportunities</li>\n<li>High attention to detail and commitment to quality</li>\n<li>Ability to travel as required to conduct on-site monitoring visits</li>\n\n<div>Base pay range for this job is $105,600-$158,400.</div>\n</div>"
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