Xeris Pharmaceuticals, Inc.
Sr. Clinical Trial Associate (Chicago Based)
Xeris Pharmaceuticals, Inc., Chicago, Illinois, United States, 60290
Sr. Clinical Trial Associate (CTA) role at Xeris Pharmaceuticals, Inc. provides administrative and project-specific support to the Clinical Team for the conduct of clinical trials. This includes assisting with study team activities, TMF documentation, obtaining study materials, and creating and maintaining clinical study trackers.
Responsibilities
Assists in study implementation and ongoing trial management under the direction of other Clinical Development Team members. Contributes to inspection readiness, including creating and updating folders and trackers for the eTMF, BIMO checklists, study team lists (internal, CRO, and vendors), internal study team meetings, study-specific documents, and other documents as requested by Clinical Operations. Tracks and maintains study information and reports on study progress as assigned. Attends study team meetings; prepares agendas, documents meeting minutes, and distributes action items. Partners with and supports CRAs and Study Managers to ensure TMF is complete and maintained. Collaborates with Regulatory, Legal, Medical, QA, and consultants to ensure sponsored clinical trials are conducted in accordance with corporate SOPs, GCP and ICH guidelines and applicable regulations. Creates, tracks, and follows up on legal requests (e.g., confidentiality agreements, contracts, and extensions/revisions). Tracks invoices and supports the clinical service provider reconciliation process and Sunshine Act reporting. Monitors clinical mailboxes and triages inquiries for appropriate follow-up. Acts as a central point of contact for the clinical team for designated projects, communications, and related documentation. Performs other tasks or responsibilities as assigned. Qualifications
Bachelor’s degree in science, nursing, or equivalent with a 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, Problem Solving, Attention to Detail, Time Management, Ability to multi-task, Self-motivated, Flexibility. Working conditions: This hybrid role is based in Xeris' Chicago office and requires a minimum of three days per week in the office. Position may require periodic evening and weekend work and potential travel up to 5%. Compensation and employment details
The anticipated base salary range for this position is $60,000 - $110,000. Final determination of base salary offered will depend on candidate skills, experience, education, market location, and business need. This role includes eligibility for bonus and equity. The total compensation package may include multiple paid time off benefits, various health insurance options, retirement benefits, and more. Details about these offerings will be provided at the time a conditional offer of employment is made. Candidates are welcome to inquire about compensation and benefits during the interview process. 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. Seniority level
Mid-Senior level Employment type
Full-time Job function
Research, Analyst, and Information Technology Industries
Pharmaceutical Manufacturing 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.
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Assists in study implementation and ongoing trial management under the direction of other Clinical Development Team members. Contributes to inspection readiness, including creating and updating folders and trackers for the eTMF, BIMO checklists, study team lists (internal, CRO, and vendors), internal study team meetings, study-specific documents, and other documents as requested by Clinical Operations. Tracks and maintains study information and reports on study progress as assigned. Attends study team meetings; prepares agendas, documents meeting minutes, and distributes action items. Partners with and supports CRAs and Study Managers to ensure TMF is complete and maintained. Collaborates with Regulatory, Legal, Medical, QA, and consultants to ensure sponsored clinical trials are conducted in accordance with corporate SOPs, GCP and ICH guidelines and applicable regulations. Creates, tracks, and follows up on legal requests (e.g., confidentiality agreements, contracts, and extensions/revisions). Tracks invoices and supports the clinical service provider reconciliation process and Sunshine Act reporting. Monitors clinical mailboxes and triages inquiries for appropriate follow-up. Acts as a central point of contact for the clinical team for designated projects, communications, and related documentation. Performs other tasks or responsibilities as assigned. Qualifications
Bachelor’s degree in science, nursing, or equivalent with a 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, Problem Solving, Attention to Detail, Time Management, Ability to multi-task, Self-motivated, Flexibility. Working conditions: This hybrid role is based in Xeris' Chicago office and requires a minimum of three days per week in the office. Position may require periodic evening and weekend work and potential travel up to 5%. Compensation and employment details
The anticipated base salary range for this position is $60,000 - $110,000. Final determination of base salary offered will depend on candidate skills, experience, education, market location, and business need. This role includes eligibility for bonus and equity. The total compensation package may include multiple paid time off benefits, various health insurance options, retirement benefits, and more. Details about these offerings will be provided at the time a conditional offer of employment is made. Candidates are welcome to inquire about compensation and benefits during the interview process. 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. Seniority level
Mid-Senior level Employment type
Full-time Job function
Research, Analyst, and Information Technology Industries
Pharmaceutical Manufacturing 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.
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