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

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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical monitoringsource data verificationcase report forms (CRFs)protocol compliancedata integrityrisk-based monitoringmonitoring visit typespatient recruitmentdata quality managementregulatory compliance

Soft Skills

organizational skillscommunication skillsproblem-solving skillsteam-orientedflexibilityattention to detailoperational guidancetraining and supportcollaborationindependent management

Certifications

Bachelor’s degree in life sciencesBachelor’s degree in nursingadvanced degree (preferred)