Lead Clinical Research Associate
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Job Location:
Cambridge, MA - USA
Monthly Salary:
$ 131200 - 196800
Posted on:
5 days ago
Vacancies:
1 Vacancy
Job Summary
About eGenesis
eGenesis is aclinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Companys proprietary genome engineering platform enables extensive multiplex gene edits to remove key biological barriers add protective human transgenes and inactivate endogenous retroviruses. EGEN-2784 agenetically engineered porcine kidney is the Companys lead program and is currently being evaluated in amulti-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
- Bachelors 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 $131200-$196800.
We may use artificial intelligence (AI) tools to support parts of the hiring process such as reviewing applications analyzing resumes or assessing responses. 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.
Required Experience:
IC
