Clinical Trial Associate

Avalo Therapeutics•Chesterbrook, PA

About The Position

At Avalo (ahh-vah'-low), we are 100% focused on developing treatments for immune-mediated inflammatory diseases with large unmet needs that affect millions worldwide. Our strategy is to develop medicines that target the IL-1β pathway, which is a central driver of the inflammatory process. We share a commitment to teamwork, passion for science, and dedication to patients suffering from acute and chronic inflammatory disorders. Our collective expertise in discovery, development, and regulatory approvals is evidenced in our strong individual track records of advancing multiple therapeutic programs to successful commercialization. Reporting to the Clin Ops Manager of Clinical Development Operations or delegate, the Clinical Trial Associate (CTA) will support the planning, execution and delivery of clinical trials in accordance with Avalo Therapeutics SOPs, ICH/GCP and applicable regulatory requirements, timelines, budget, and quality standards. This role will partner closely with the Clinical Operations study management team to ensure efficient study management. This is a 6-month contract with potential conversion to full time employment.

Requirements

Bachelor’s degree in life sciences or healthcare-related field.
Minimum of 2-5 years of experience in a relevant field, e.g., clinical site, CRO, Sponsor or clinical trial vendor (sponsor experience preferred).
Working knowledge of ICH GCP regulations and clinical protocols.
Strong computer skills, including Smartsheet, Excel, Word, PowerPoint, SharePoint, Veeva, and Outlook.
Sound analytical and problem-solving skills; ability to act with a sense of urgency.
Demonstrated effectiveness in resolving complex site management issues.
Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling, and meeting deadlines.
Ability to work in a fast-paced environment with demonstrated agility to juggle multiple competing tasks and demands.
Excellent written and verbal communication skills.
Team player that takes initiative and is willing to support optimizing the way we work.

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. Working with the Clinical Trial Manager, 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.
Oversee TMF Quality Review for study team; complete TMF QC for the department quarterly for each study, including collecting, reviewing, and submitting documents to the TMF.