Job Description

Overview

The in-house CRA is responsible for performing remote site management activities in support of Xeris clinical studies, ensuring adherence to protocols, timelines, ICH/GCP guidelines, and federal regulations. The in-house CRA will support operational aspects of assigned clinical studies from study start-up through study conduct to close-out.

Responsibilities

• Serves as a central point of contact for investigator sites and as a liaison between the study team, investigator sites, and vendors to facilitate effective communication and resolution of issues.
• Collects, reviews, and monitors required essential documentation for study start-up, study maintenance and study close-out.
• Supports IRB submission of applicable study related documents (protocols, informed consents, participant facing documentation, etc.).
• Assists to manage and maintain essential documents for the electronic trial master file (eTMF) ensuring studies remain inspection ready.
• Supports the setup, testing and maintenance of documentation to clinical systems (Clinical Trial Management Systems [CTMS], electronic data capture [EDC], Interactive Response Technology [IRT], etc.) and related supporting documents (manuals, completion guidelines, etc.) in collaboration with other study team members and/or external vendors as applicable.
• Performs data analysis and review from EDC systems and site performance indicators to monitor study progress and ensure protocol adherence. Proactively monitors for trends or issues related to deviations or anything which might jeopardize participant safety or study data integrity.
• Assists with resolution of data queries from investigator sites.
• Supports centralized risk-based monitoring oversight activities as assigned.
• Supports site identification, feasibility and selection activities.
• Assists with tracking and reporting of study enrollment, monitoring metrics and trends.
• Supports audits/inspections/inspection readiness activities through collaboration with relevant clinical sites to prepare for and respond to audit/inspection findings conducted by internal QA or external regulatory agencies as applicable.
• Performs other tasks or responsibilities as assigned.

Qualifications

• Bachelors degree (B.A./B.S.) or equivalent in life sciences or related discipline.
• 4+ years experience as an In-house Clinical Research Associate or comparable experience.
• Knowledge of trial oversight activities, GCP/ICH and federal regulations, IRB/EC and Investigator responsibilities.
• Knowledge of IRB guidelines and processes
• Familiarity with clinical trial systems (i.e. CTMS, EDC, eTMF, etc.).
• Strong computer skills, including a high level of proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, etc.).
• Ability to work independently and as part of a team.
• Competencies: Multi-Tasking, Teamwork & Collaboration, Attention to Detail, Self-Starter, Analytical skills, Problem Solving, Organizational skills, Adaptability, Strong Written and Verbal Communications.
• Working Conditions: This is a hybrid role based in Xeris Chicago office and requires a minimum of three days per week in the office. On-site requirements may change at managements discretion. Position may require occasional evening and weekend work, as necessary to fulfill obligations. Occasional overnight travel. Travel up to 10%.

Equal Opportunity

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 - $100,000. 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.

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