2018 Internship Program: Translational Clinical Oncology (TCO) Intern

Job description

Job Description

Translational Medicine is a global, scientifically focused group which operates under the research arm of Novartis: the Novartis Institute of BioMedical Research (NIBR). Scientists and clinicians within the Translational Clinical Oncology (TCO) are primarily responsible for designing and conducting early phase clinical trials in patients with cancer. These trials explore the safety, tolerability, pharmacokinetic (PK), pharmacodynamics (PD), and initial efficacy of small molecules, biologics, or cell-based therapies. The Summer Intern will be exposed to the life cycle of clinical trials, from understanding the operational aspects of study start-up, maintenance and close out processes. The goal of this internship program is to provide exposure on how to conduct Phase I/II oncology clinical trials in a pharmaceutical company.

Objectives:

The Summer Intern may participate in the following activities during the program:
- Learn the TCO structure and molecule lifecycle within Novartis
- Learn the General Overview of Trial Life Cycle, Start Up, Maintenance and Close Out
- Review GCP/ICH Guidelines
- Review the commonly used abbreviations on the Novartis website
- Learn which documents, tasks, activities and responsibilities are in each part of the life cycle of the clinical trial and where they specifically fall as deemed appropriate by the preceptor
- Review the Protocol & Respective Guidance Documents
o Concept Slides – what they contain and where they come from
o Protocol Synopsis – what is included for information, how it is generated, who generates it, who reviews it, timeframe for these steps
o Protocol Drafting – how this happens regarding information collection and generation, who contributes what to the document, how coordination meetings are approached, who reviews the document, how this moves forward
o Protocol Review Committee (PRC) meeting – why we have it, what happens before/during/after that meeting and next steps after the meeting
o Pregnancy language and Guideline on Prevention of Pregnancies in Clinical Trials
- Review the Informed Consent Form (ICF) & Respective Guidance Documents
o Who generates this, how it is generated
o Who reviews and approves the document
- Review what’s included in the Investigator Brochure (IB)
o Why do we need this document, how it is generated
- To learn and understand the various responsibilities within data management
o Examples of electronic Case Report Forms (eCRFs), both annotated and the live database should be shown and explained
o Examples of Case Report Form (CRF) Completion Guidelines CCGs should be shown and explained
o Learn and understand what protocol deviations are and how its documented
- Review and understand various documents filed in CREDI
o Show/review relevant study related documents
- Review the Trial Master File
o eTMF (what it is and related trackers), TMF TOC
- Review the Clinical Study Report (CSR)
o CSR appendices
- Shadow Preceptor in Various Meetings: the various meeting should be explained (EPT, GPT, CTT, DEM, IM, etc.) and slide deck examples should be shown when available

EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

Desired profile

Minimum requirements

Minimum requirements:

• Must be attending an accredited graduate school program (e.g pharmacy school, medical school, masters program, or PhD program)
• Basic understanding of Microsoft applications (e.g Word, Outlook, Excel)
• Good communication, organization & tracking skills

Preferred Competencies/Experience:

• Basic knowledge of oncology and/or hematology (optional)
• Basic understanding of the drug development process (Phase I-IV) clinical trials (optional)