Lead CRA / Principal CRA

Jobtailor; Center Square (PA); On-site; USD 110,000 - 140,000; Full time

Job summary

Jobtailor is seeking an experienced Clinical Trial Monitor with a strong background in oncology trials to manage site relationships, oversee monitoring visits, and ensure inspection readiness. The role emphasizes remote and on-site qualifications, training for FSP CRAs, and collaboration with sponsors to accelerate enrollment and milestones.

Ideal candidates will have 8+ years of oncology monitoring experience, familiarity with Veeva CTMS and TMF, and a proven track record of ensuring GCP

Qualifications

• Completion of a bachelor’s degree in a scientific or clinical field is required
• 8+ years monitoring Oncology (solid tumor) trials, with a minimum of 4 years monitoring phase I and/or Phase III Oncology, is required
• Previous experience independently conducting on-site and remote monitoring visits, including site qualification, initiation, monitoring, and close-out, is required
• Experience utilizing Veeva CTMS and TMF is required
• Experience supporting site and/or sponsor inspections is preferred
• Experience auditing sites and TMF is preferred
• Legal right to work in the country where the role is based
• Advanced degree is preferred

Responsibilities

• Develop and maintain strong clinical trial site relationships to support positive site/patient experience and accelerate enrollment and study milestones
• Promote awareness of the sponsor’s clinical pipeline and programs to trial sites, investigators, and networks
• Conduct Monitoring Oversight Visits to assess FSP CRA monitoring quality and site inspection readiness
• Execute remote or on-site site qualification and facilitate site selection
• Schedule and conduct Site Initiation, Interim Monitoring, and Close-Out visits to co-monitor, train, and onboard FSP CRAs across oncology trials
• Review and approve FSP CRA Monitoring Visit Reports
• Review site and monitoring KRI metrics, detect issues, ensure resolution, and contribute to the Study and Site Risk Assessment Tool
• Train and retrain FSP CRAs and sites on GCP, protocols, vendor processes, and study-specific documents
• Manage sites, resolve monitoring quality issues, and develop or ensure implementation of site CAPA Plans
• Ensure sites are inspection-ready and support the sponsor during site inspections
• Use CTMS and TMF to file SEME and site documents, maintain accurate site data, and audit site TMFs as needed
• Draft, review, or contribute to Site Monitoring Plans
• Contribute to monitoring process improvement through SOPs, Work Instructions, job aids, and tools
• Improve site selection, monitoring, and oversight templates in Veeva CTMS and EDC by identifying gaps, testing, and implementing change controls
• Establish relationships with investigators, site staff, sponsor study team members, and FSP CRAs

Skills

Oncology Trial Monitoring

Veeva CTMS

GCP Compliance

Site Qualification

Monitoring Visit Execution

Education

Bachelor's degree in a scientific or clinical field

Tools

CTMS

TMF

EDC

Veeva CTMS

Job description

• Develop and maintain strong clinical trial site relationships to support positive site/patient experience and accelerate enrollment and study milestones


• Promote awareness of the sponsor’s clinical pipeline and programs to trial sites, investigators, and networks


• Conduct Monitoring Oversight Visits to assess FSP CRA monitoring quality and site inspection readiness


• Execute remote or on-site site qualification and facilitate site selection


• Schedule and conduct Site Initiation, Interim Monitoring, and Close-Out visits to co-monitor, train, and onboard FSP CRAs across oncology trials


• Review and approve FSP CRA Monitoring Visit Reports


• Review site and monitoring KRI metrics, detect issues, ensure resolution, and contribute to the Study and Site Risk Assessment Tool


• Train and retrain FSP CRAs and sites on GCP, protocols, vendor processes, and study-specific documents


• Manage sites, resolve monitoring quality issues, and develop or ensure implementation of site CAPA Plans


• Ensure sites are inspection-ready and support the sponsor during site inspections


• Use CTMS and TMF to file SEME and site documents, maintain accurate site data, and audit site TMFs as needed


• Draft, review, or contribute to Site Monitoring Plans


• Contribute to monitoring process improvement through SOPs, Work Instructions, job aids, and tools


• Improve site selection, monitoring, and oversight templates in Veeva CTMS and EDC by identifying gaps, testing, and implementing change controls


• Establish relationships with investigators, site staff, sponsor study team members, and FSP CRAs

Requirements

• Completion of a bachelor’s degree in a scientific or clinical field is required


• 8+ years monitoring Oncology (solid tumor) trials, with a minimum of 4 years monitoring phase I and/or Phase III Oncology, is required


• Previous experience independently conducting on-site and remote monitoring visits, including site qualification, initiation, monitoring, and close-out, is required


• Experience utilizing Veeva CTMS and TMF is required


• Experience supporting site and/or sponsor inspections is preferred


• Experience auditing sites and TMF is preferred


• Legal right to work in the country where the role is based


• Advanced degree is preferred

Core Competencies

Demonstrates expertise in Oncology Trial Monitoring, including site qualification, initiation, and oversight, while ensuring compliance with GCP and regulatory standards. Proficient in utilizing Veeva CTMS and TMF for effective site management and documentation.

Highest-signal resume keywords

• Oncology Trial Monitoring


• Veeva CTMS


• GCP Compliance


• Site Qualification


• Monitoring Visit Execution

Hard Skills

• Clinical Trial Monitoring


• Site Inspection Readiness


• Site Risk Assessment


• Monitoring Quality Issue Resolution


• Site CAPA Plans


• Site Monitoring Plans


• KRI Metrics Review


• Study-Specific Document Training


• Phase I Oncology Monitoring


• Phase III Oncology Monitoring

Soft Skills

• Relationship Management


• Training and Onboarding


• Problem Solving


• Communication

Industry Keywords

• Clinical Trials


• Oncology


• Solid Tumor Trials


• Site Management


• Monitoring Oversight Visits

Tools & Technologies

• CTMS


• TMF


• EDC