Clinical Research Associate I

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 collaborative and detail-oriented CRA I. The successful candidate will work closely with the Eikon Site Engagement and Monitoring Excellence (SEME) management team, Functional Service Provider (FSP) CRAs and internal study teams across therapeutic areas to monitor clinical trial data; qualify, select and initiate sites; manage and develop site relationships to support study deliverables; and support SEME's utilization of Veeva systems.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our Millbrae, CA office to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.

About You

You have some remote monitoring experience and are adept at developing and maintaining relationships with clinical trial sites to secure compliance and study deliverables. You have a solid understanding of Good Clinical Practice and clinical trial regulations to ensure subject safety, data integrity and inspection readiness. You are a strong collaborator with a demonstrated ability to work across clinical trial team functional areas. You have experience supporting monitoring activities such as reconciling Essential Documents, tracking monitoring visits and associated documentation, and collating site intelligence to ensure it is captured in Veeva systems.

What You'll Do

• Lead and execute site engagement projects to develop and maintain strong clinical trial site relationships to support a positive site/patient experience and accelerate the progress of Eikon study milestones.
• Perform site management activities to support Senior/Lead CRAs and site success.
• In collaboration with a Senior/Lead CRA or SEME Manager, co-monitor at Interim Monitoring Visits (remote or on-site) and support Site Initiation Visits/Close-Out Visits.
• Independently execute remote or on-site qualification (Pre-Study Site Visits) of sites for Eikon trials and promptly facilitate site selection by completing the Site Selection checklist.
• Independently reconcile Investigational Product (IP) accountability records (remote or on-site) to conduct IP monitoring.
• Develop site monitoring tools to facilitate monitoring visit preparation.
• Lead SEME site outreach efforts to promote continuous improvement in data entry cycle times in preparation for monitoring visits and Eikon study milestones.
• Support entry and migration of monitoring and site intelligence data into Veeva systems.
• Effectively utilize Veeva CTMS and TMF to ensure SEME and site documents are promptly filed and site data is accurate.

Qualifications

• Bachelor's degree (scientific or clinical field preferred) and a minimum of 2 years of related experience working in clinical and/or scientific research.
• Remote clinical site monitoring experience preferred.
• A minimum of 1 year utilizing Veeva CTMS, CDMS (EDC), RTSM (IRT) and TMF for clinical research is required.
• Site travel of approximately 25% may be required for this role; this travel percentage could occasionally increase to meet urgent business needs. When not travelling, the position is based in Eikon's Millbrae, CA office.

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 $87,000 to $95,000 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.