Global Development Clinical Intern

Overview:

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.

Responsibilities:

• 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.

Qualifications:

• 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

• 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.

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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.