Clinical Trial Associate

Main Responsibilities

• Create and/or review study plans, specification documents, materials, and tools.
• Support outsourced activities to Clinical Research Organizations (CROs) and other third-party vendors for assigned activities.
• Responsible for tracking study progress in CTMS, including site activation, patient enrollment, patient status, oversight of Regulatory documents for site initiation and close out.
• Deliver and execute operational tasks, and assist in tracking study metrics, maintenance, and distribution of study trackers.
• Collaborate with clinical trial sites to develop relationships and support the collection of relevant study materials and documentation.
• Review documents for completeness, accuracy, and compliance with protocol and appropriate regulations; Identify issues and take appropriate corrective actions.
• Assist in preparing or review study-related documents (i.e., ICF, clinical trial tools, templates, training materials, manuals, study newsletters, etc.).
• Support project meeting logistics such as: calendar management, room and equipment set up, collation of materials, and attendance tracking.
• Prepare meeting agendas and draft, finalize, and distribute meeting minutes.
• QC oversight of CRO, TMF, Monitoring Visit Reports, Payments, Safety Alert acknowledgments, ICFs, protocol amendments, and study close out.
• Build strong professional relationships with vendors, and individuals at all cross functional levels of the organization.
• Track payments to vendors and study sites as appropriate.

About the role

Avalo Therapeutics is a clinical stage biotechnology company fully dedicated to developing therapeutics targeting the IL-1β pathway for immune-mediated inflammatory diseases. Our lead asset, abdakibart, is an anti-IL-1β monoclonal antibody (mAb). Positive topline data was recently reported for abdakibart in a Phase 2 clinical trial in hidradenitis suppurativa (HS). In addition to HS, we’re exploring additional opportunities to make an impact in prevalent indications that have significant remaining unmet needs. We are also advancing AVTX-010, a long-acting next-generation anti-IL-1β mAb designed to extend dosing intervals and build upon the differentiated profile established by abdakibart. For more information about Avalo, please visit www.avalotx.com.