Sr. Clinical Trial Associate

The Sr. Clinical Trial Associate (CTA) will be responsible for providing Clinical Team members with administrative and project-specific support related to the conduct of clinical trials. This includes assisting with study team activities, assisting with Trial Master File (TMF) documentation, and performing other administrative tasks. In addition, the Sr. CTA will be responsible for obtaining study materials and creating and maintaining clinical study trackers.

• Assists in study implementation and ongoing trial management under the direction of other Clinical Development Team members.
• Contributes to inspection readiness, including, but not limited to, creating and updating various folders and trackers for the eTMF, BIMO checklists, study team lists (internal, CRO and vendors), internal study team meetings, study specific documents and all other documents as requested by Clinical Operations
• Tracks and maintains study information and reports on study progress as assigned
• Attends study team meetings; prepares study team agendas, documents meeting minutes and distributes study team agenda(s), meeting minutes and action items
• Partners with and support CRAs and Study Managers, ensuring TMF is complete and appropriately maintained.
• Partners with other departments (Regulatory, Legal, Medical, QA, etc.) and consultants ensuring that sponsored clinical trials are conducted in accordance with corporate SOPs, GCP and ICH Guidelines and applicable federal and local regulations.
• Creates, tracks and follows up on legal requests (eg. Confidentiality agreements, contracts, agreement extensions/revisions).
• Tracks invoices and supports the clinical service provider reconciliation process and Sunshine Act reporting.
• Monitors Clinical mailboxes and triages for appropriate follow up.
• Act as central point of contact for the clinical team for designated projects, communications, and associated documentation.
• Performs other tasks or responsibilities as assigned.

• Bachelor’s degree in science, nursing, or equivalent with minimum of 4 years of Clinical Trial experience.
• In-depth working knowledge of FDA regulations, ICH guidelines, and GCP governing the conduct of clinical trials.
• Familiarity with pharmaceutical and medical terminology.
• Experience with eTMF and CTMS platforms.
• Microsoft Office Suite proficiency (Outlook, Word, Excel, PowerPoint).
• Competencies: Adaptability, Organizational skills, Project Management, Team Collaboration, Verbal and Written Communication skills, Problem Solving skills, Attention to Detail, Time Management, Ability to multi-task, Self-motivated, Flexibility

• Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. This is a hybrid role based in Xeris’ Chicago office and requires a minimum of three days per week in the office. On-site requirement may change at management’s discretion. Potential travel up to 5%.

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As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law.  It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.

The anticipated base salary range for this position is $60,000 - $110,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process.  

NOTE:  This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.