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 Senior 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 monitor, qualify and initiate sites, ensure data quality and manage site relationships to support study deliverables.
About You
You have significant monitoring experience and are adept at developing and maintaining relationships with clinical trial sites to secure compliance and study deliverables. You have experience independently monitoring and possess 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.
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.
- 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.
Qualifications/Requirements
- Typically requires a minimum of 8+ years of experience with a Bachelor's Degree, or 6+ years of experience with a Master's degree.
- Proven experience monitoring Oncology (solid tumor) trials with demonstrated experience 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.
- Experience supporting site and/or sponsor inspections is preferred.
- Site travel of approximately 50-75% is required; this travel percentage could increase to meet urgent business needs.
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 $130,000 to $142,500 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.
