The Lead Clinical Research Associate leads site monitoring activities, oversees CRAs, ensures compliance with protocols and regulations, and develops monitoring tools for clinical trials.
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.
The Lead Clinical Research Associate is responsible for leading site monitoring activities and providing oversight to CRAs for assigned clinical trials. The Lead CRA works closely with Clinical Operations leadership and cross-functional teams to ensure that studies are conducted according to protocol, ICH-GCP guidelines, regulatory requirements, and company SOPs.
PRIMARY RESPONSIBILITIES
- 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
QUALIFICATIONS
- Bachelor’s degree in life sciences, nursing, or related field required; advanced degree preferred
- 5+ years of clinical monitoring experience in the pharmaceutical, biotechnology, or CRO industry, including experience directly conducting and overseeing all monitoring visit types (e.g., site qualification, site initiation, routine monitoring, oversight monitoring and close-out visits). Across the full study lifecycle
- Demonstrated ability to perform monitoring activities as a site CRA and provide operational guidance to CRAs in a Lead CRA or equivalent role
- Experience monitoring complex clinical trials, involving critically ill or high-acuity patient populations (e.g., gene/cell therapy or transplant)
- Experience working with academic centers and/or investigator sites that have limited experience with industry-sponsored clinical trials
- Experience supporting clinical systems development and testing, including CRF/EDC User Acceptance Testing (UAT) and/or IRT/RTSM UAT
- Hands-on experience using CTMS to manage monitoring activities, track site performance, with working knowledge of eTMF and electronic data capture (EDC) systems
- Strong knowledge of ICH-GCP guidelines, regulatory requirements and clinical trial operations
- Strong organizational, communication, and problem-solving skills
- Team oriented and flexible with ability to respond effectively to shifting priorities
- High attention to detail and commitment to quality
- Ability to travel as required to conduct on-site monitoring/oversight visits
Base pay range for this job is $131,200-$196,800.
Top Skills
Crf
Ctms
Edc
Electronic Data Capture
Etmf
Irt
Rtsm
eGenesis Cambridge, Massachusetts, USA Office
300 Technology Sq, Cambridge, MA, United States, 02139
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