Clinical Research Coordinator Level 2 Programme

26 MAR 2024

Course Date

July 2024 Intake: 04, 05, 11, 12, 18, 19 July 2024

Every Thursday / Friday from 9:00am to 6.00pm.

Course Duration

Approximately 3 weeks / 6 days

Course Location

NTU@One-North (Buona Vista)

Registration Period

 01 February to 01 March

Note: The programme is currently held once a year

Course Description

The Clinical Research Coordinator (CRC) Level 2 Programme builds on a CRC’s fundamental competencies in clinical trials and examines the complexities of investigator-initiated trials and multi-center clinical research studies. The programme is designed to empower CRCs with project management skills and the ability to coordinate investigator-initiated clinical research studies with reasonable degree of proficiency across a range of study designs. Application of skills will be reinforced through classroom discussion, case scenarios and practice-based activities.

Learning Outcomes

  • Define sponsor responsibilities in an investigator-initiated study

  • Apply project management concepts to manage time, resources and quality issues

  • Coordinate and perform secretariat duties for multi-site project meetings

  • Develop study documents such as data collection tools

  • Manage research materials, biological specimens and site logistic matters

  • Implement the operational workflow and quality systems for the research study

  • Explain the IRB and regulatory requirements for sponsors

  • Track project status and completion of study procedures

  • Develop the ability to anticipate and mitigate potential risks or non-compliance

  • Highlight key concepts for the preparation and conduct of study monitoring and development of a study monitoring plan

Who Should Attend

  • Senior CRCs,

  • CRCs who are carrying out job responsibilities equivalent of a Senior CRC, and

  • CRCs who are progressing towards Senior CRC job grade

Entry Requirements

All requirements must be fulfilled:

  • At least 4 years of experience in coordinating clinical trials;

  • Has experience in participant recruitment, obtaining informed consent, participant visit follow-up, IRB submissions, source documentation, maintenance of essential documents, safety reporting and management of investigational product.

CRCs, who do not possess a comprehensive fundamental knowledge in clinical trials, may wish to attend the CRC Level 1 Programme prior to applying for the CRC Level 2 Programme.

Course Outline

Day One 

  • Responsibilities of Sponsor PI in Investigator-initiated Multi-centre Trial

  • Fundamentals of Project Management

  • Develop and Establish Quality Systems for Research Study

Day Two

  • Protocol Review & Safety Monitoring

  • Application of Project Management Knowledge on Site Feasibility

  • Project Organisation Structure & Process

Day Three

  • Resource Management and Study Budget

  • Data Collection & Management

Day Four

  • Study Template Design

  • Management of IM and SIV

  • IRB & Regulatory Requirements for Clinical Research

  • Research Grant Management

Day Five

  • Management of Clinical Research Materials

  • Management of Biological Specimens

  • Management of Trial Master File

  • Enhance Recruitment Strategies for IIT

Day Six

  • Quality Control: Study Monitoring

  • Project Management During Study

  • How to Be Inspection Ready

  • Site Readiness for Closure

*Kindly note that the course outline may be subjected to changes without prior notice.

Technical Requirements

**This is only applicable if the programme is conducted virtually.

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

  1. Use of PC or Laptop to access the Zoom virtual class 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

To register for the CRC Level 2 Programme, applicants and their supervisors must complete the following electronic registration forms below.

Registration Form

Registration Form (Section C)

[To be completed by Applicant]

[To be completed by Supervisor / Reporting Officer]
Registration Form QR Code for CRC L2 Programme
Form C QR Code for CRC L2 Programme

https://for.sg/l2registration

https://for.sg/l2sectionc

Registration priority will be given to CRCs core-funded under the NMRC CRC programme. Priority will also be given to CRCs from Singapore’s public healthcare institutes under MOH Holdings.

Course Fees (inclusive of GST)

Full Price

$3,885

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

$430

Qualification

Participants who successfully completed all modules of this programme with at least 75% class attendance will receive a certificate of Completion (CRC Level 2 Programme) from SCRI Academy.

To download the programme brochure, please click here.

Enquiries

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