Lead Clinical Research Associate

Summary

Join Eikon Therapeutics, a biopharmaceutical company, as a Lead Clinical Research Associate (CRA). You will collaborate with the SEME team and FSP CRAs to oversee monitoring, ensure data quality, and manage site relationships. This role requires significant monitoring experience in oncology trials and a passion for training and mentoring. You will develop and maintain strong relationships with clinical trial sites, ensuring subject safety and data integrity. The position involves conducting monitoring visits, reviewing reports, and contributing to process improvements. Eikon offers competitive compensation and benefits.

Requirements

• Completion of a bachelor’s degree (scientific or clinical field) is required
• 8+ years monitoring Oncology (solid tumor) trials (with a minimum of 4 years monitoring phase I Oncology) is required
• Previous experience independently conducting on-site and remote monitoring visits (site qualification, initiation, monitoring, and close-out) is required
• Experience utilizing Veeva CTMS, CDMS, RTSM and TMF (a minimum of 2 years) is required
• Experience supporting site and/or sponsor inspections is required
• Site travel of approximately 50-75% is required; this travel percentage could increase to meet urgent business needs or decrease in cases when remote monitoring and Oversight Visits occur

Responsibilities

• Develop and maintain strong clinical trial site relationships to support a positive site/patient experience and accelerate the progress of study milestones such as enrollment and major study milestones
• Promote awareness of Eikon’s clinical pipeline and programs to trial sites, investigators, and networks
• Conduct Monitoring Oversight Visits on behalf of Eikon to assess FSP CRA monitoring quality and site inspection readiness
• Execute remote or on-site qualification of sites for Eikon trials as needed, and promptly facilitate site selection
• Schedule and conduct Site Initiation, Interim Monitoring and Close-Out visits as needed to co-monitor, train and/or onboard FSP CRAs across oncology trials. On-site visits are preferred at Eikon
• Review and approve FSP CRA Monitoring Visit Reports
• Regularly review site and monitoring Key Risk Indicator metrics to detect issues and ensure prompt resolution across regional territory. Contribute to development of the Study and Site Risk Assessment Tool
• Train and re-train FSP CRAs and sites on GCP, the protocol, vendor processes and study-specific documents
• Perform consistent site management and act as an escalation point for FSP CRAs to resolve monitoring quality issues; develop/ensure implementation of site Corrective and Preventive Action (CAPA) Plans and escalate to study teams as needed
• Ensure sites are inspection-ready and support Eikon during site inspections
• Effectively utilize the Clinical Trial Management System (CTMS) and Trial Master File (TMF) to ensure that SEME and site documents are promptly filed, and site data is accurate; audit the site TMFs as needed
• Independently draft, review or contribute to the development of a Clinical Site Monitoring Plan as needed
• Contribute to monitoring process improvement initiatives by reviewing and/or developing functional area Standard Operating Procedures (SOPs), Work Instructions (WIs), job aids, and tools
• Contribute to improving site selection, monitoring, and monitoring oversight trip report templates in CTMS and Electronic Data Capture (EDC) by identifying gaps, suggesting updates, testing and implementing change controls as needed
• Establish and foster effective relationships with internal and external stakeholders, such as investigators, site staff, Eikon study team members and FSP CRAs

Preferred Qualifications

• An advanced degree is preferred
• Experience auditing sites and TMF is preferred

Benefits

• 401k plan with company matching
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
• Mental health and wellness benefits
• Weeklong summer and winter holiday shutdowns
• Generous paid time off and holiday policies
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
• Enhanced parental leave benefit
• Daily subsidized lunch program when on-site
• Bonus and equity compensation