Global Development Clinical Intern

This position will support the Xeris Clinical Development department with ensuring our studies and clinical trials are managed in accordance with Xeris procedures and any local and Federal regulatory requirements.  This role will be introduced to various aspects of Clinical drug development, Medical, Pharmacovigilance and Regulatory. The intern will gain an understanding of the clinical research operational activities across all phases of clinical research, become familiar with the essential documents required and gain a cross functional appreciation of drug development through interfacing with key internal and external collaborators and participating in wider study team discussions.

• Assist in the implementation of new systems and tools to streamline clinical trial operations
• Assess the impact of ICH E6 (R3) on clinical documents (eg. templates, SOPs) and implement changes to affected documents.
• Develop templates for clinical documentation according to Good Clinical Practice (GCP) and regulatory guidelines.

• Perform tasks related to supporting operational execution of clinical studies, including trial master file documentation filing and reviews, preparation of materials, and study inspection readiness activities.
• Work on assigned projects and participate in study team activities and meetings.
• Assist in review of key study documentation including protocols, informed consent forms, investigator brochures, case report forms, and clinical study reports.
• Perform other duties, as assigned.

• Pursuing a bachelor’s degree in Clinical Research, Life Sciences or Pharmaceuticals
• Proficiency in Microsoft Office – Must have intermediate level Excel skills
• Highly organized and with attention to details
• Display good oral and verbal communication skills
• Ability to prioritize tasks and drive a project to completion within deadlines
• Ability to work independently and as a team
• Familiarity with statistical software such as SAS and basic knowledge of statistical concepts and methods are a plus
• Competencies:  Teamwork & Collaboration, Attention to Detail, Analytical skills, Problem Solving, Organizational skills, Project Management, Adaptability, Professionalism, Written and Verbal Communications, Presentation skills, Strategic Vision

Working Conditions

• Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.
• This role is based in Xeris’ Chicago office and requires five days per week in the office. On-site requirement may change at management’s discretion.

#LI-ONSITE

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 hourly pay for this position is $16.75 per hour. 

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.