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Clinical Trials

Course Outline
Develop a career in clinical trials in the pharmaceutical, medical device or academic sectors as a clinical trialist, data manager, quality manager, project manager, clinical research nurse, research associate or pharmacovigilance associate with experts in the HRB Clinical Research Facility, UCC. This Postgraduate Certificate Clinical Trials is a wholly online, part-time course designed for the working professional. Students can expect to dedicate up to 20 hours per week. Study areas include the fundamentals of clinical trials, clinical trial design and analysis, ethics, data management and quality in clinical trials. On successful completion of these three 10-credit modules, students should be capable of designing and running a simple clinical trial. Experienced clinical trialists, who bring practical application to teaching, coordinate and teach the Postgraduate Certificate in Clinical Trials. Join us on our exciting journey improving clinical trial methodology and patient focused research to advance the health of our citizens.

Course Practicalities
Students of the Postgraduate Certificate Clinical Trials can expect to devote up to 20 hours/week to the course. A guide per 10-credit module is:
• 80hr(s) directed study (online self-directed learning);
• 40hr(s) directed study (online moderated activities);
• 40hr(s) other (written assignment reflection and development (submitted online));
• 40hr(s) other (reading and reflective practice).

Why Choose This Course
This Postgraduate Certificate Clinical Trials is designed to give a competitive advantage for those wishing to pursue a career in clinical trials in the pharmaceutical, medical device or academic sectors. It is the first such course in Ireland and is provided by the HRB Clinical Research Facility at UCC, a world class centre of excellence, with experts in clinical trial design and analysis. The PG Certificate Clinical Trials provides a pathway for progression to Postgraduate Diploma Clinical Trials and ultimately a MSc Clinical trials, and is the only course designed and paced for the working professional. With three 10-week semesters, a week in the middle and end to catch up and complete work, this learning experience is for the busy you. Physicians, nurses, dentists, managers, scientists, health scientists, food scientists and workers in the allied health professions are encouraged to apply. Experienced clinical trialists, who bring practical application to teaching, coordinate and teach the Postgraduate Certificate in Clinical Trials. Clinical trials is a rapidly expanding discipline with exciting new job opportunities in the healthcare and pharmaceutical sectors, e.g. data manager, clinical research associate, clinical research nurse, project manager, trial monitor, regulatory affairs associate, pharmacovigilance associate etc. Join us on our exciting journey promoting clinical trials and patient focused research to improve the health of our citizens.

Entry requirements

Requirements
1. Students accepted on the Postgraduate Certificate in Clinical Trials are expected to hold an honours primary degree (NFQ Level 8), minimum second class honours grade 2, or equivalent, in a Science or health related discipline, or relevant subject area.
2. The Postgraduate Certificate in Clinical Trials is also open to registered (not necessarily in current employment) health care professionals in Medicine, Nursing, Pharmacy, Clinical Therapies and Allied Health care disciplines who may not have a primary degree. Such applicants must provide evidence of current registration with the relevant professional regulatory body in their country (e.g. the Irish Medical Council, the Nursing and Midwifery Board of Ireland, the Pharmaceutical Society of Ireland etc. for Irish applicants).
3. All applicants will be required to write a 500-word personal statement on why they wish to pursue a career in clinical trials.
4. In exceptional circumstances, applicants with an honours primary degree (NFQ Level 8 or international equivalent) in an unrelated field, and who can demonstrate relevant experience in clinical research, may be considered for entry to the programme, subject to the approval of the programme team.
5. Applicants may be asked to participate in an interview.
6. In all cases, decisions will be based on qualifications and quality of application.

Exemptions
As part of UCC's commitment to Continuing Professional Development (CPD), students who have successfully completed a module from the Postgraduate Certificate in Clinical Trials as a CPD module and subsequently undertake the programme within 24 months will be exempt from that module.

Technical Requirements
This programme will be delivered wholly online. To access and interact with the course content, assignments and assessments etc., students will require:
1. Access to a laptop or desktop (either Mac OS or Windows) running a relatively recent operating system (Windows 7 or Mac OSX 10.8 or later). Tablets and smartphones are not officially supported by UCC.
2. Access to a reliable broadband connection with at least 2MB download speeds.
3. A modern standards compliant web browser. The most reliable options for use with UCC online learning are Mozilla Firefox and Google Chrome. Download and installation instructions will be provided. Safari is not suitable.
4. Common plug-ins such as Java and Flash Runtimes. Download and installation instructions will be provided.
5. An Office suite of software (Microsoft Office 2003 or later or equivalent) and a PDF reader (preferably Adobe Acrobat Reader XI or later).

English Language Requirements
Applicants that are non-native speakers of the English language must meet the university approved English language requirements available at https://www.ucc.ie/en/study/comparison/english/postgraduate/

International/non-EU applicants
For full details of the non-EU application procedure please visit our how to apply pages for international students. In UCC, we use the term programme and course interchangeably to describe what a person has registered to study in UCC and its constituent colleges, schools, and departments.

Not all courses are open to international/non-EU applicants, please check the fact file above.

For more information please contact the International Office.

Duration

9 Months Part-Time
Course Delivery Method Online

Careers or further progression

Skills and Careers Information
On completion of the course you can pursue a career in the academic, pharmaceutical or medical device sectors as a
• Clinical Trialist
• Quality Manager
• Project Manager
• Trial Monitor
• Data Associate
• Data Manager
• Clinical Research Nurse
• Clinical Research Associate
• Research Coordinator
• Pharmacovigilance Associate
• Regulatory Affairs Associate

Further enquiries

Contact details for this course
Dr Frances Shiely
f.shiely@ucc.ie
+353 21 420 5512
https://www.ucc.ie/en/crfc/staff/

Ms Aoife Quinlan
a.quinlan@ucc.ie
+353 21 420 5577

Subjects taught

Modules
• EH6123 Fundamentals of Clinical Trials (10 credits)
• EH6124 Introduction to Clinical Trial Design and Analysis (10 credits)
• EH6125 Ethics, Data Management and Quality in Clinical Trials (10 credits)

Assessment method

Assessments can be expected to comprise of discussion fora, individual project and other online assessments. Each 10-credit module comprises continuous assessment 200 marks, divided as follows: Online activities 120 marks; and Written Assignment(s) 80 marks. The compulsory elements are continuous assessment, online participation in discussions and written assignment.

Application date

Applications for academic year 2020/2021 are open.

EU Applicants: UCC operates a rounds closing date system for the majority of postgraduate taught courses, which means offers are made four times a year on a rolling basis. Some courses have one specific closing date, please check your course prospectus page for this information.

The UCC rounds closing dates for postgraduate taught courses are below. Applicants are advised to apply as soon as possible.

Deadline for receipt of full applications:
For all completed applications received by January 10th 2020
Offers will be made by January 24th 2020

For all completed applications received by March 2nd 2020
Offers will be made by March 16th 2020

For all completed applications received by May 1st 2020
Offers will be made by May 15th 2020

For all completed applications received by July 1st 2020
Offer will be made by July 15th 2020

Late applications may be accepted on a first-come, first-served basis for any courses that have remaining capacity.

Course fee

The fee for this course is €3,600.

Enrolment and start dates

Start Date: 21 September 2020

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