Clinical Research Coordinator Level 1 Programme

26 MAR 2024

Course Date

January Intake:

01 January to 30 April

June Intake:

01 June to 30 September

Click here for the class schedule

From 9:00am to 6:00pm

Course Duration

January Intake

Class 1A: 16 weeks E-learning + 3-day In-person tutorial session

Class 1B: 16 weeks E-learning + 3-day In-person tutorial session

June Intake

Class 2A: 16 weeks E-learning + 3-day In-person tutorial session

Class 2B: 16 weeks E-learning + 4-half day virtual* tutorial session

*Training delivery for Virtual tutorial session would differ from physical tutorial session with adjustment made to suit the online format.

Course Location

CRIS Office (23 Rochester Park Singapore 139234)

(Kindly note the course location may be subjected to changes.)

Registration Period

For every January Intake:

01 October to 30 October

For every June Intake:

01 March to 31 March

(Registration is based on first-come-first-serve basis)

Course Description

  • The Clinical Research Coordinator (CRC) is a specialised research professional working with the research investigator to ensure smooth progress of the research project. The CRC Level 1 Programme (Blended) is designed for CRCs with at least one year of experience and who are interested in gaining knowledge about coordinating clinical research. The programme offers a comprehensive introduction to the operations of clinical research at site and practical, hands-on training through the blended learning approach to provide flexible and effective learning. Participants will self-learn through the interactive study materials, followed by face-to-face (F2F) classroom sessions (in-person or virtual) to reinforce the application of core CRC skills through classroom discussions, case scenarios, demonstrations and practice-based activities. This programme is also valuable for individuals seeking a new career as a CRC.

    • The SCRI Academy was launched in August 2017 by the Senior Minister of State (Ministry of Health and Ministry of Transport) to house the training efforts for CRCs. The SCRI Academy is part of the Singapore Clinical Research Institution (SCRI), which is a business unit under the Consortium for Clinical Research and Innovation Singapore (CRIS), a wholly owned subsidiary of MOH Holdings.

    • This training programme is funded by the Ministry of Health in collaboration with Health Sciences Authority, Singapore Health Services, National Healthcare Group, National University Health System, and Nanyang Polytechnic.

Learning Outcome

  • Describe the clinical trial activities from study initiation to closure

    • Discuss the importance of Good Clinical Practice

    • Understand the investigator and sponsor responsibilities in a clinical trial

    • Define the requirements for ethics submissions, source documentation and essential documents

    • Discuss the informed consent process

    • Discuss strategies for subject recruitment and retention

    • Prepare your site for a monitoring visit

    • Define safety reporting guidelines

    • Describe the process for management of investigational product at site

Who Should Attend

  • CRCs with at least one year of experience

Entry Requirements

  • At least 1 year of current experience as a CRC or equivalent duties

Course Outline

Face to Face Session (In-person/Virtual)

  • Site start-up activities

  • Research Team

  • Study Budget

  • Source Documentation

  • Essential Document

  • Screening & Recruitment

  • Informed Consent

  • Study Follow-up & Discontinuation

  • Amendment, Continuing Review and Other Reporting to IRB

  • Site Closure

  • Randomisation & Unblinding

  • IP Management

  • Clinical Trial Regulatory Requirements

  • Operational Challenges of Early Phase Trials

  • MCQ Examination

E-Learning (16 weeks)*

  • Introduction to Clinical Research

  • Research Team

  • Protocol Feasibility

  • Clinical Trial Agreement

  • Study Budget

  • Elements of Protocol

  • Ethics Board & Submission - DSRB/CIRB

  • Site Start-up Activities

  • Informed Consent

  • Screening and Recruitment

  • Amendment, Continuing Review & other reporting to IRB

  • Safety Reporting to IRB

  • Source Documentation

  • Subject Follow-up & Discontinuation

  • Essential Document

  • Clinical Data Management & CRF Queries

  • Randomisation & Unblinding

  • Investigational Product Management

  • Investigator Meeting and site initiation

  • Monitoring Visit Preparation

  • Site Closure Activities

  • Study Closure Checklist

  • Research Misconduct and Fraud

* This is an e-learning module. If required, guidance and support will be provided by the trainers via email. 

**Please note that the above schedule may be subjected to changes.

E-Learning Module

Participants will be given access to the e-learning materials one month before and after the F2F classroom sessions. Participants are required to complete all e-learning videos and quizzes by Week 16 of the programme.

Technical Requirements

**This is only applicable if the F2F classroom session is conducted virtually.

It is mandatory to fulfill ALL the following minimum technical requirements:

  1. Use of PC or Laptop for MCQ Examination, as the system is not compatible on Mobile devices (e.g. mobile phone or tablets). You are also strongly encouraged to access the Zoom virtual class via a PC or Laptop for better learning experience as you need to refer to the training handouts while attending the class.

  2. Stable internet connection (3G or 4G/LTE), with minimum bandwidth of 600kbps is recommended.

    • You can check your Internet bandwidth using www.speedtest.net or http://bandwidthplace.com/.

  3. Supported browser versions:

    • Windows: IE11+, Edge 12+, Firefox 27+, Chrome30+

    • Mac: Safari 7+, Firefox 27+, Chrome30+

    • Linux: Firefox 27+, Chrome 30+

  4. Headphone (preferred) or speaker to listen in (built-in / USB plug-in / wireless Bluetooth)

  5. Microphone for class discussion (built-in / USB plug-in / wireless Bluetooth)

  6. Webcam (built-in / USB plug-in). It is compulsory to turn on the camera for the duration of the Zoom virtual class for attendance authentication.

Application Procedure

Registration is by first come first serve basis. Applicants and their supervisors must complete the registration form.

An automated email would be routed to your supervisor for endorsement. Please notify your supervisor when you have completed and submitted the form.

Registration Form

Please scan the QR Code OR click the link below to access our registration form.

L1 Registration

Link: https://for.sg/l1registration

Course Fees (Inclusive of GST)

Full Price

$3,255

CRCs from Singapore’s Public Healthcare Clusters under MOH Holdings (After subsidy)

$360

Qualification

Participants who have completed all modules of the programmes and have obtain an overall grading of 75% will obtain a Certificate of Achievement (CRC Level 1 Programme) from SCRI Academy.

To download the programme brochure, please click here.

Enquiries

For enquiries, please contact scriacademy@scri.cris.sg.