Specialist Certificate in Clinical Trials - The University of Melbourne

Graduate Programs in Clinical Trials Monitoring & Coordination

Specialist Certificate in Clinical Research (Clinical Trials Monitoring)
Specialist Certificate in Clinical Research (Clinical Trials Coordination)

Course Introduction

The University of Melbourne, in partnership with ARCS Australia Ltd are pleased to offer an opportunity for clinical research professionals the opportunity to provide an opportunity for clinical research professionals to take part in one of two courses that we have jointly developed to give you with a clear pathway for your ongoing career development. Bringing together the industry knowledge of ARCS Australia and the teaching and learning skills of the University, we can now offer University of Melbourne award courses to recognise the commitment that you are making to your own career development.

Using flexible delivery to meet the needs of busy clinical research professionals, each student will work with ARCS Australia to develop a personalised program to meet their learning needs. Modules can be undertaken nationally through ARCS Australia and are combined with relevant professional work experience in the workplace.

Course Objectives

Clinical Trials Coordination

The Specialist Certificate in Clinical Trials (Clinical Trials Coordination) will prepare new study coordinators to effectively coordinate and manage clinical trials at their investigational site.

Clinical Trials Monitoring

The Specialist Certificate in Clinical Trials (Clinical Trials Monitoring) will prepare new CRAs to undertake clinical trial monitoring and enable them to play a more substantial role in the management and operations of clinical trials.

Which Course is right for me?

If you are a new study coordinator and you've learnt your trade on the job, you should enrol in the Specialist Certificate in Clinical Research (Clinical Trials Coordination). This course will provide you with the information, requirements, techniques, tips and inside knowledge you need to effectively coordinate and manage trials at your investigational site and to take your trial form HREC submission to managing multi-centred studies for a range of clinical trials.

If you are a Clinical Research Associate (CRA) and you want to improve your skills to allow you to more effectively monitor and manage investigational trial sites, you should enrol in the Specialist Certificate in Clinical Research (Clinical Trials Monitoring). This course will provide you with the information, requirements, techniques, tips and inside knowledge you need to allow you to develop your capabilities from clinical trial monitoring to the project management of investigational trial Sites.

Course Entry Requirements

Be a full member of ARCS Australia Ltd
Have an undergraduate degree or equivalent qualification in medicine, nursing, an allied health profession, science or social science which is recognised by the University of Melbourne
Meet the english language requirements of the University of Melbourne
Have documented evidence of at least 6 months full-time relevant professional work experience
Have documented evidence that they will be able to undertake relevant professional work experience during the course

Course Brochure

Specialist Certificate in Clincial Trials (Clinical Trials Monitoring)

Specialist Certificate in Clinical Trials (Clinical Trials Coordination)

Course Structure

Each of the Specialist Certificates comprises two subjects, both of which must be completed to earn the Specialist Certificate award. More details on the individual courses and their content can be found in the course brochures.

Specialist Certificate in Clinical Research (Clinical Trials Coordination)

Subject 1: Clinical Trial Site Establishment (360908)

There are three core modules in this subject, all of which must be completed:

Subject 2: Clinical Trial Site Coordination (360907)

This subject comprises a group of elective modules that are selected in consultation with ARCS Australia plus a capstone subject
The capstone module Coordinating single and multi-centered research more effectively is completed as the last module of the course

Specialist Certificate in Clinical Research (Clinical Trials Monitoring)

Subject 1: Clinical Trial Site Monitoring (360909)

There are three core modules in this subject, all of which must be completed:

Subject 2: Clinical Trial Site Management (360910)

This subject comprises a group of elective modules that are selected in consultation with ARCS Australia plus a capstone subject
The capstone module Managing your trial sites more effectively is completed as the last module of the course.

Electives (for both courses)

The selection of appropriate electives for each student will be made in consultation with ARCS Australia. The electives currently available are:

Course Delivery

The content for the courses is delivered by ARCS Australia, at venues in Melbourne, Sydney and Brisbane. The dates for the delivery of these modules can be found at www.arcs.com.au

Course Assessment

The following assessments apply to both courses:

Subject 1 Assessment

One open book test representing 20% of the total mark
Two 1000 word assignments, each representing 25% each of the total mark
One 1500 word workplace assignment representing 30% of the total mark

Subject 2 Assessment

One assignment for each elective, with a combined word count of at least 2000 words and a total contribution of 40% of the marks for the subject
One 2000 word assignment for the capstone module, representing 40% of the total marks
One 1000 word overall workplace assignment representing 20% of the marks

Please note that in each suject, students must achieve a mark of at least 50% in each assessment to achieve a pass grade for that subject.

Time Commitment

Each subject of the specialist certificate involves 24 hours of lectures. In addition to face-to-face teaching time, students should expect to undertake a minimum of 120 hours research, reading, writing assignments and general study to complete this subject successfully.

Course Fee

Course fees for 2009 are A$4,400. ($2,200 per subject). These fees are GST exempt.

How to Apply

New Applications are managed by the Student Services Team. Click here for the Application Form and further instructions.

Once your application has been received by the University of Melbourne, we will send you a short Training Plan which you will be asked to complete and send to ARCS Australia. This training plan will be used:

To verify your ARCS Australia membership status
To document your relevant work experience
To confirm your ability to undertake a work-based project
For initial selection of your electives and the times, dates and locations of the modules in which you will be enrolled.

Further Enquiries

It is possible that during the course of the year, you may have questions about the content or perhaps the administration of the program. There are a number of people who are there to assist with any issue you may wish to raise.

For enquiries about the course content and delivery dates:

Joe Badolato

T: +61 2 8905 0829

F: +61 2 8905 0830

E: joebadolato@arcs.com.au

Student Services can assist with queries about online enrolment, invoicing, change of address and withdrawal or enrolment in a subject.

Student Services

T: +61 3 9810 3245

F: +61 3 9810 3149

E: postgrad@mccp.unimelb.edu.au

For other enquiries:

John Bates

T: +61 3 9810 3103