Senior Clinical Research Associate

Summary

Join Eikon Therapeutics, a biopharmaceutical company, as a Senior Clinical Research Associate (CRA). You will be part of the Site Engagement and Monitoring Excellence (SEME) team, collaborating with FSP CRAs and internal study teams. This role requires significant monitoring experience in oncology trials, strong knowledge of GCP and clinical trial regulations, and the ability to manage site relationships. You will be responsible for site qualification, monitoring visits, data quality, and ensuring inspection readiness. The position involves approximately 50-75% travel, with potential for increased travel to meet urgent business needs. Eikon offers a competitive salary and a comprehensive benefits package.

Requirements

• Completion of a bachelor’s degree (scientific or clinical field is preferred) is required
• 6+ years monitoring Oncology (solid tumor) trials (with a minimum of 3 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 (EDC), RTSM (IRT) and TMF (a minimum of 2 years) is required
• Site travel of approximately 50-75% is required; this travel percentage could increase to meet urgent business needs

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
• Execute remote or on-site qualification of sites for Eikon trials, and promptly facilitate site selection
• Schedule and conduct Site Initiation, Interim Monitoring and Close-Out visits as needed for multiple oncology trials. On-site visits are preferred at Eikon
• Regularly review site and monitoring Key Risk Indicator metrics to detect issues and ensure prompt resolution
• Train and re-train sites on GCP, the protocol, vendor processes and study-specific documents
• Perform consistent site management and resolve monitoring quality issues; develop/ensure implementation of site Corrective and Preventive Action (CAPA) Plans and escalate 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 SEME and site documents are promptly filed and site data is accurate
• 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 Veeva 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 and Eikon study team members

Preferred Qualifications

• An advanced degree is preferred
• Experience supporting site and/or sponsor inspections 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