eGenesis

Senior Clinical Research Associate

Cambridge, MA · Senior

Sponsorship not specified$106k-$158kDetected 131 days ago

GCPComplianceClinical TrialsClinical ResearchResearchLeadershipCommunicationProblem Solving

About the role

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.

Support site start-up and activation activities, including collection, review, and tracking of regulatory and essential documents
Partner with investigative sites to support patient recruitment and retention efforts and address enrollment barriers
Evaluate site operational challenges, implement practical solutions to support site performance and study compliance, and escalate significant issues project leadership as appropriate
Support risk-based monitoring activities by evaluating site performance indicators and identifying emerging operational or compliance risks
Perform source data verification and review case report forms (CRFs) to ensure completeness, accuracy, and compliance with study requirements
Train and support Principal Investigators and site staff on protocol procedures, regulatory requirements and GCP compliance
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

4+ years of clinical monitoring experience in the pharmaceutical, biotechnology, or CRO industry
Experience managing sites with high data volume and ensuring timely source documentation, CRF completion, and query resolution
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
Familiarity with eTMF, CTMS, and electronic data capture (EDC) systems
ability to respond quickly to shifting demands and opportunities
Bachelor's degree in life sciences, nursing, or related field required; advanced degree preferred
Experience managing academic medical center sites and supporting investigators or site teams with limited experience in industry-sponsored IND trials
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 organizational, communication, and problem-solving skills
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

This listing is sourced directly from eGenesis's careers page and normalized into a canonical job model.