Lead CRA / Principal CRA

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Cultivate and sustain robust relationships with clinical trial sites to enhance the site and patient experience while accelerating study milestones.

• Increase awareness of the sponsor’s clinical pipeline and programs among trial sites, investigators, and networks.

• Conduct Monitoring Oversight Visits to evaluate the quality of FSP CRA monitoring and ensure readiness for site inspections.

• Carry out remote or on-site site qualification and facilitate the selection of sites.

• Organize and perform Site Initiation, Interim Monitoring, and Close-Out visits to co-monitor, train, and onboard FSP CRAs involved in oncology trials.

• Review and authorize FSP CRA Monitoring Visit Reports.

• Analyze site and monitoring Key Risk Indicator metrics and contribute to the Study and Site Risk Assessment Tool.

• Provide training and re-training for FSP CRAs and sites on GCP, protocols, vendor processes, and study-specific documents.

• Manage site operations and serve as an escalation point for issues related to FSP CRA monitoring quality.

• Create or ensure the execution of site CAPA Plans and escalate issues when necessary.

• Guarantee that sites are prepared for inspections and assist the sponsor during site inspections.

• Use CTMS and TMF to organize documents, maintain accurate site data, and audit site TMFs as required.

• Draft, review, or contribute to the development of Site Monitoring Plans.

• Participate in initiatives aimed at improving monitoring processes, SOPs, work instructions, job aids, and tools.

• Enhance site selection, monitoring, and monitoring oversight templates in Veeva CTMS and EDC.

• Build relationships with investigators, site personnel, sponsor study team members, and FSP CRAs.

⛳️ Requirements

• A bachelor’s degree in a scientific or clinical field is mandatory.

• An advanced degree is preferred.

• A minimum of 8 years of experience monitoring Oncology (solid tumor) trials, including at least 4 years of monitoring phase I and/or Phase III Oncology, is essential.

• Proven experience in independently conducting on-site and remote monitoring visits (site qualification, initiation, monitoring, and close-out) is required.

• Proficiency in using Veeva CTMS and TMF is necessary.

• Experience in supporting site and/or sponsor inspections is preferred.

• Familiarity with auditing sites and TMF is preferred.

• Must have the legal right to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, which may include medical, dental, and vision coverage.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.