Clinical Site Monitoring Assistant (Contractor)

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Job description

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

The Clinical Site Monitoring Assistant (contractor) will be responsible for performing supportive activities to facilitate site management and monitoring deliverables throughout the clinical trial lifecycle. This role will support the Site Engagement and Monitoring team to ensure data integrity, subject safety, and system/site inspection readiness at the clinical investigative sites in the United States (US).

About You

You have experience working in Clinical Veeva Vaults, including CTMS and TMF. You have experience supporting monitoring activities including reconciling Essential Documents, tracking monitoring visits and associated documentation, and collating monitoring and site intelligence to ensure it is captured in the systems.

What You'll Do

• Perform supportive and administrative site management activities to support CRA and site success and maintain a continuous state of inspection readiness in the Veeva systems
• Perform quality control checks of remote and on-site monitoring/co-monitoring visits (Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits and Close-Out Visits) to ensure visit documentation is aligned with monitoring visits
• Maintain the site monitoring calendar
• Develop site monitoring tools and materials/metrics to facilitate monitoring visit preparation
• Perform qualify control reconciliation checks (site files vs TMF)
• Support data migration of monitoring and site intelligence into Veeva systems

Qualifications

• Bachelor's degree (completed or in progress)
• Experience working with Veeva CTMS and TMF
• Experience supporting a field-based oncology monitoring group

The expected hourly range for this role is $23.56/hour to $25.57/hour 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.

In accordance with the Company's duty to provide and maintain a safe workplace, the Company requires all employees to be Fully Vaccinated with one of the FDA approved COVID-19 vaccines, which includes those vaccines that have received the FDA's emergency use authorization. You will be expected to be Fully Vaccinated as of your Start Date. If you believe that you are exempt from this requirement under an applicable law or regulations, including Americans with Disabilities Act and California's Fair Employment and Housing Act, you will need to contact the Company's Human Resources group. For purposes of this section, Fully Vaccinated means (i) the completion of the vaccination regimen as approved by the FDA (by way of example, 2 doses of the Pfizer or Moderna vaccine and 1 dose of the Johnson and Johnson vaccine), and (ii) timely receiving booster vaccination, as recommended by the Centers for Disease Control and Prevention.

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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