New

Lead Clinical Research Associate (East Coast)

Remote (East Coast)

Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.

Position

We are seeking a highly experienced, collaborative, and detail-oriented Lead Clinical Research Associate (CRA). The successful candidate will work closely with the Eikon Site Engagement and Monitoring Excellence (SEME) team, Functional Service Provider (FSP) CRAs and internal study teams across therapeutic areas to oversee monitoring, ensure data quality and manage site relationships to support study deliverables.

About You

You have significant monitoring experience and a passion for training and mentoring other CRAs. You are adept at developing and maintaining relationships with clinical trial sites and demonstrate the ability to execute monitoring with a strong knowledge of Good Clinical Practice and clinical trial regulations to ensure subject safety, data integrity and inspection readiness. You are a strong collaborator across clinical functional areas with a demonstrated ability to creatively and independently resolve complex issues that impact sites. You are able to successfully develop and maintain positive site relationships in parallel with ensuring optimal trial conduct and quality at Eikon clinical trial sites. You are able to objectively assess monitoring quality and compliance with the Clinical Site Monitoring Plans to drive Eikon’s oversight of monitoring activities and deliverables.

What You’ll Do 

  • 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.

Qualifications/Requirements

  • Completion of a bachelor’s degree (scientific or clinical field) is required. An advanced degree is preferred.
  • 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.
  • Experience auditing sites and TMF is preferred.
  • 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.

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:​

  • 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​

The expected salary range for this role is $139,000 to $152,000 depending on skills, competency, and the market demand for your expertise.

Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.

We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.

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