Aspiring Clinical Research Associate

Name:Job Title:Company:

When writing your essay, please ensure that you cover all the points in the text below, and that it adheres to the following rules:

Maximum 1000 words; this includes all wording in tables, diagrams and bulleted lists (title and repetition of the title at the beginning of your essay, are not included in this count)

A word count must be included with your submission. Essays exceeding the word count will be deemed void by the judges. Please present in an essay format (the use of tables, bulleted lists and diagrams are

encouraged) Please use the free plagiarism checker: www.plagscan.com and include the output with your

essay. Do not refer to your name or company within your submission. Your entry should be

anonymised. Word format only (PDF document, will not be accepted)

Stage 2 Challenge

The job of a Clinical Research Associate is challenging with many, often urgent, priorities to juggle, even when you are at site. It is the responsibility of a Clinical Research Associate to self-manage and organize their time appropriately. Plans frequently have to be adjusted throughout the day. A Clinical Research Associate needs the ability to evaluate accurately each situation/request, and the flexibility to adjust priorities appropriately.

Part A

Imagine you are a CRA and you are about to perform the first monitoring visit at a site for a paediatric oncology study for Children aged from 2yrs to 17 yrs. The site has screened three patients and randomised two, the first patient is 10 yrs, 2 months old, and the second is 23 months old.

The medication needs to be made up under aseptic conditions, the site does not have these facilities, but the private hospital next door does and they have agreed to assist with this study.

The site has four Sub-Investigators, two of whom have been added to the team since the site initiation visit.

Discuss the tasks you need to perform today, prioritise them and provide considerations and reasoning for your prioritisation.

Part B

During your source data review, you discover that patient #1 was too ill to attend the study site and went to a more local hospital for a protocol required (not standard of care) scan as advised by the study coordinator.

What actions would you put in place?

What are the considerations do you need to think about?

Please explain any considerations and your reasons for what needs to happen for this patient. Taking into account your overall responsibilities and also stakeholder management and relationships.

Also consider if you need to change your plans for the day explain why and what mitigations you might put in place for anything you cannot cover during your visit.

Completed challenges are to be sent by email to: samuel.mcintyre@pharmatimes.com by 30/01/2019

The Clinical Singles finals will be on the 21/03/2019. Please keep this date available