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Clinical & Translational

Course Features
Designed for science graduates seeking employment in the fast growing clinical research industry
Course content designed in collaboration with industry
Delivers course content in an intensive 12-week period
Equips graduates with recognised employment advantage
Based at the UCD Clinical Research Centre

Course Overview

This intensive 12-week programme - delivered in partnership with ICON plc, a global leader in clinical research - is designed for recent science graduates who wish to pursue a career in industry-led research e.g. pharmacuetical, biotechnology or clinical research organisations.

The programme features expert-led modules in clinical trials management, data management and project management as well as an immersive, internship-style research project.

Who should take this course?
If you are interested in being part of teams that focus on innovative patient focused research, this programme is for you. Led by Dr Peter Doran, Director of the UCD Clinical Research Centre, this programme is designed for recent science graduates, who wish to gain a competitive employment advantage in order to pursue a career in bio/pharmaceutical research, biotechnology or within the medical device sector

Delivered in partnership with ICON, a leading clinical research organisation - an Irish company founded in 1990; now a leading clinical research organisation with more than 1000 employees - the programme provides essential business, programme management and technology skills as well as practical experience of clinical trials and data management.

How will I learn?
To complete the UCD Grad Cert in Clinical Research you will
Participate in 12 weeks of Study
Earn 30 ECTS credits
Complete 3 different modules
Successfully pass all assessments and examinations

You will need to successfully complete the following 3 modules, to generate 30 ECTS credits
Clinical trials
Data Management & Biostatistics
Clinical Trial Management

Entry requirements

Essential Criteria

Applicants must possess a Level 8 degree or equivalent in any science subject.

Assessment for Entry

Applicants will be assessed for entry to the programme based on the following criteria:
Undergraduate performance and final degree award

Selection
Subject to a large volume of applicants meeting the essential and preferred criteria, random selection may apply
Applicants may be asked to participate in an interview

More Information
Subject to availability, consideration will be given to graduates of non-science degrees who have subsequent postgraduate experience.
As the clinical research industry is global, demonstrated proficiency in another language may be considered positively.

Duration

X635 4 Months Full Time

Number of credits

30

Careers or further progression

This course is specifically designed for individuals wishing to pursue subsequent employment within the pharmaceutical, biotechnology or medical device sector or within contract clinical research organisations (CRO's).

Further enquiries

Dr Peter Doran
Director, UCD Clinical Research Centre
UCD School of Medicine & Medical Science
Catherine McAuley Education & Research Centre
Mater Misericordiae University Hospital
Nelson Street
Dublin 7
Email: crc@ucd.ie

Subjects taught

Course Content

This course requires completion of 5 modules; 4 required, and a choice of 1 of 2 optional modules.

Semester One - (Core Modules)

Principles and Practice of Clinical & Translational Research

This module forms part of the Graduate Certificate/Diploma/MSc in Clinical & Translational Research. The goal of this module is to provide an overview of the knowledge, skills and competencies that will allow them to complete a programme of clinical and translational research. Specifically, this Module will:

Explain the study designs used in clinical & translational research
Discuss practical methods for management of data and biological samples obtained during clinical & translational research studies
Discuss the range of methods available for the analysis of samples obtained from clinical & translational research
Explain statistical methods used to design and analyse clinical & translational research projects
Review standards of Good Clinical Practice and Good Laboratory Practice in the conduct of clinical and translational research

On completion of this course students will demonstrate advanced knowledge of clinical & translational research methods. Specifically, students will be able to:
Understand clinical & translational research principles, including study design
Understand core methodologies used in the conduct of clinical & translational research, including data management, biological sample handling/storage, and basic data analysis
Analyse the design of clinical & translational research projects

Data Management for Clinical Research

This module forms part of the Graduate Certificate in Cinical & Translational Research and the Graduate Diploma in Health Informatics. The goal of this module is to introduce students to key concepts in data management for clinical research. Specifically this Module will: - introduce students to the importance of data management for clinical research - identify and evaluate source data - describe methodologies for collection of data - describe the creation of a data management plan for clinical research

On completion of this course students will be able to:
Understand the importance of data management
Understand core considerations, including data security, source data, etc.
Create a data management plan for a clinical research project

Semester Two - (Core Modules)

Advanced Research Methods

This module prepares students working, or intending to work, in a population health or clinical setting to undertake all elements of a research project from concept through design, implementation and analysis to interpretation and presentation of findings. The focus of this module is primarily on quantitative methods, though applications to qualitative research is also covered.

At the end of this module students should be able to:
design a quantitative epidemiological study to be carried out in a clinical, occupational or scientific setting
develop a Research Protocol to a specified framework
prepare a submission to a Research Ethics Committee to specified standard
know the major epidemiological study designs
choose the design most appropriate to the research question
be familiar with relevant sources and types of data
understand sampling methods and recruitment strategies
understand power calculations / sample size estimation appropriate to the study design
design and evaluate study instruments, including questionnaires and Case Report Forms
oversee processes of data management, including data collection, entry and editing
select appropriate statistical techniques for study data
carry out basic statistical analysis
interpret study data and present results

Biorepositories for Clinical & Translational Research

The goal of this module is to introduce students to key concepts in the collection, processing and storage of biological samples for clinical and translational research. Specifically, this Module will:
introduce students to infrastructure of biorepository
introduce students to the methodology of sample collection, processing and storage
inform students of core ethical and legal considerations around sample collection
describe in detail the theory and practicality of collection of all types of biological materials
provide students with skills needed to create and execute a sampling plan
provide students with invaluable practical experience of sample collection and processing

On completion of this module, students will be able to:
understand the theory of biological material preservation
understand the infrastructure needed to develop a biorepository
gain practical experience in sample handing and processing
create a sampling plan understand sample validation and quality control

Course structure

Semester One
Principles and Practice of Clinical & Translational Research (10 Credits)
Data Management for Clinical Research (5 Credits)

Semester Two
Biorepositories for Clinical & Translational Research (5 Credits)
Clinical Protocol Development (10 Credits)

Assessment method

Examinations are by MCQ, projects, presentations, and practical examinations. There will also be continual assessment throughout the course.

Enrolment and start dates

Next Intake: 2017/2018 September.

* Courses will remain open until such time as all places have been filled, therefore early application is advised.

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