About COUR

COUR is a clinical stage biotech company with a mission to restore health in autoimmune patients by developing first-in-class, disease-modifying, targeted therapies to safely regulate and calm the immune system.  Our portfolio consists of three mid-to-late-stage proprietary programs: PBC, myasthenia gravis (MG), and type 1 diabetes (T1D), and our platform positions us to broaden our impact in antigen-specific autoimmune conditions.

About the role

Reporting to the Head of Clinical Operations or a designated manger/director in Clinical Operations, the Clinical Trial Assistant (CTA) will be responsible for providing operational and program level support across multiple clinical trials under the leadership of the assigned Clinical Trial Manager (CTM).  This role includes supporting the study team in planning, set-up, maintenance, and closeout of clinical trials, as applicable.

The successful candidate will partner with cross-functional teams internally as well as with external partners to contribute to milestones across clinical programs.

This role has a strong focus on ensuring that clinical trial site activities and document management operations are performed with adherence to ICH-GCP guidelines, regulatory requirements, and standard operating procedures (SOPs).

What you'll do

·        Support the clinical study team ensuring trial deliverables are met according to timelines, budget, operational procedures, and quality standards.  Assigned responsibilities can include development of specific sections of study related documents, study tools, guidelines, and training materials.

·        Support study team by setting up and maintaining appropriate study tracking via CTMS or manually, including but not limited to vendor and site information, start-up information, and study contact lists.

·        Provide support for review of Trial Master File (TMF) documentation, follow-up for documentation within the study teams, and ongoing reconciliation of study documentation.

·        Provide support in meeting scheduling, meeting agendas, and meeting minutes when required, including the closed sessions of the Data Monitoring Committee meetings.

·        Serve as the primary point of contact to clinical sites throughout study life cycle.

·        Supports CRA during on-site visits as needed.

·        Assist the clinical study team with preparation and distribution of study tools throughout the trial.

·        Participate in process improvements, as required.

Qualifications

·        2+ years clinical research support of clinical trials or equivalent experience

·        Experience supporting multiple clinical trials required.

·        Knowledge of ICH-GCP guidelines and regulatory requirements related to clinical trial management.

·        Experience with technology-based tracking and document management systems such as clinical trial management systems (CTMS), eTMF, and clinical data management tools (e.g., eCRFs).

·        Ability to achieve high performance goals and meet timelines in a fast-paced environment.

·        Strong organization skills with attention to detail and follow-through.

·        Working knowledge of Microsoft Office applications including Word, Excel, SharePoint, and PowerPoint

·        Adaptable to effectively support multiple competing demands and changing priorities.

·        Proactive approaches to problem-solving.

·        Effective communication skills to internal and external team members.

·        Willing to travel to home office (Skokie, IL) approximately 1-2 times per year.