Research Associate

Overview of Company:

Equillium (www.equilliumbio.com) is a clinical stage biotech company (NASDAQ:EQ) focused on developing novel therapies for severe and life threatening autoimmune and inflammatory diseases. Equillium’s initial product candidate, itolizumab, is a clinical-stage, first-in-class monoclonal antibody that selectively targets the CD6-ALCAM pathway. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. Itolizumab is a clinically-validated therapeutic that has demonstrated a favorable safety and tolerability profile. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited. Biocon has recently reported results from a study of itolizumab in COVID-19 patients in India, and has subsequently received emergency use authorization from the Drugs Controller General in India for itolizumab for the treatment of cytokine release syndrome (CRS) in COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS).  Equillium believes that itolizumab has the potential to be a best-in-class disease modifying therapeutic and is developing itolizumab in multiple severe immuno-inflammatory disorders – acute graft-versus-host disease, uncontrolled asthma, and lupus nephritis – and is planning to submit an IND for the treatment of COVID-19 patients.  

Overview of Position: Under minimal supervision in Clinical Operations, works with the team to coordinate the activities associated with the evaluation, initiation and management of clinical trials and study sites. May assist in managing clinical studies including site and/or vendor oversight.

 

Essential Duties & Responsibilities:

  • Assist with study site CDAs, feasibility, and selection
  • Coordinates and assists with the activities associated with site start-up and overall study site management, including review of site documents in anticipation of site activation and site oversight through close-out
  • Review and management of site documents
  • Review, tracking and documentation of monitoring reports
  • Identification and escalation of issues and assists with corrective action plans
  • Provides review and input on study-specific plans
  • Coordinates the review and content of study materials such as eCRFs, study guides and site/subject instructions
  • Assists with the preparation, conduct and presentations for CRA Training
  • May assist with the coordination and management of study site budgets
  • Manages the overall site investigational product accountability and reconciliation process
  • Assists with the review and oversight of data (EDC and vendor data) for quality (e.g. ensures CRF data queries are resolved and data reconciles, i.e. AEs and Medical History to con meds)
  • Coordinates CRO tracking, and training, including lab samples
  • eTMF support and management; assurance of ongoing document maintenance and completion of study files, checking eTMF and assisting with loading documents and follow-up on missing items. Must be able to identify what documents should be posted in the eTMF per study status and manage to fulfillment.
  • Builds CRO relationships and provides oversight on vendor performance
  • Assists with program oversight, identifies deficiencies and risks, and assists with improvement and mitigation plans
  • Ensures compliance with Equillium policies and procedures
  • Intermittent clinical site monitoring for adherence to protocol and GCP
  • May complete site visits in assistance of CRO and to promote timeline
  • Review of clinical protocols and amendments, as needed
  • Other duties as assigned

Job Requirements: Education: BA/BS in Biological Sciences or related field, or BSN/RN

 

Experience:

  • 5 years (2-3 years for CRA) related experience in life sciences or medically related field, including 4 years of experience in industry within Clinical Development (Sr. CRA)
  • Experience with development of prospective site-selection criteria
  • Protocol input experience
  • Familiar with advanced concepts of clinical research
  • Ability to deal with time demands, incomplete information or unexpected events
  • Experience with interactions with outside vendors (i.e. sites, CROs, contract labs) and all functions of clinical research
  • Experience with reviewing adequacy of site-proposed documents for compliance with relevant regulations

Skills and Attributes:

  • Attention to detail
  • Excellent time management and organizational skills
  • Proven ability to manage multiple tasks and associated deadlines
  • Exceptional and timely communication and interpersonal skills
  • Strong computer literacy, including: SharePoint, Microsoft Excel, Word, Outlook and PowerPoint
  • Flexibility to adapt in a cross-functional and dynamic, “start-up” type environment
  • Travel required 10-50%, as needed E
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Equal Opportunity Employer