Clinical Trial Coordinator

Icosavax, Inc. (NASDAQ: ICVX) is a publicly traded biopharmaceutical company leveraging its innovative VLP platform technology to develop vaccines against infectious diseases, with an initial focus on life-threatening respiratory diseases. Icosavax’s VLP platform technology is designed to enable multivalent, particle-based display of complex viral antigens, which it believes will induce broad, robust, and durable protection against the specific viruses targeted. Icosavax’s pipeline includes vaccine candidates targeting respiratory syncytial virus (RSV), human metapneumovirus (hMPV), and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Based in Seattle, Icosavax was formed in 2017 to advance the breakthrough VLP technology from the Institute for Protein Design at the University of Washington with the goal to discover, develop, and commercialize vaccines against infectious diseases.
Icosavax seeks an experienced Clinical Trial Coordinator to support specified clinical projects under the guidance of the Clinical Operations Manager. The Clinical Trial Coordinator will be involved in maintaining clinical trial documents in the eTMF, review clinical monitoring reports, facilitate internal meetings, and provide general support to the Clinical Operations and Clinical Development team as needed.
Provide general administrative support; scheduling and coordination of meetings; material and document distribution and/or shipments; coordination of correspondence, copying, electronic filing, etc.
Draft meeting agendas and minutes as needed
Review and track monitoring reports from Clinical Research Organization (CRO) to ensure safety, compliance and proper conduct throughout the trial as required by regulatory directives/guidelines and by sponsor and/or vendor SOPs
Ensure clinical trial eTMF’s are “inspection ready” at all times and eTMF documents are filed contemporaneously in a timely manner
Assist with clinical invoices and timeline tracking
Review and revise clinical study documents, manuals, training material as requested;
Circulate documents (i.e., protocols, informed consent forms, participant facing material, vendor project plans, etc.) for review and approval
Liaise with CRO to ensure completeness and quality of files within eTMF
Support Clinical Operations Managers with study-specific tasks as needed and provides weekly updates to team
Other duties as assigned
Bachelor’s degree in life sciences or other field related to human study preferred. An equivalent combination of education and applicable job experience may be considered.
2+ years of relevant industry experience
Previous experience with early phase trials essential
Knowledge of GCP, FDA and ICH regulations/guidelines and industry best practices
Familiarity with eTMF, EDCs, and/or other clinical electronic systems
Proficiency with Microsoft Outlook, Excel, Word, PowerPoint and TMF Reference Model; basic understanding of Smartsheet
Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
Location: Remote or office-based in Seattle
Must be eligible to work in the USA
To reduce the presence and severity of COVID-19 cases in the workplace and in our communities, Icosavax requires all newly hired employees to be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state and local law.
The salary range for this position is $31.00 – $43.00 per hour; the final hourly rate will be determined based on knowledge, skills, education, experience relevant to the role and location. This role is also eligible for equity compensation. Employees are offered health insurance (medical, dental, vision), health savings account with company contribution, flexible spending account, life insurance, short- and long-term disability, employee stock purchase plan, 401(K) plan with company contribution, vacation, sick and safe time, company holidays and floating holidays.

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