Clinical Research Coordinator (CRC) Level 2 Programme [UPCOMING]

scri-logo

More details on the course dates and registration period will be released soon!

In view of the COVID-19 outbreak, the finalized course date and registration period will be released at a later stage.

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 2 years of experience in coordinating clinical research studies;
  • Has experience in subject recruitment, informed consent and/or subject follow-up; and
  • Has basic understanding of clinical research, such as IRB requirements, ICH Good Clinical Practice, source documentation, 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 Study
  • Fundamentals of Project Management
  • Quality Management System
  • Study Design and Coordinating Protocol Development
Day Two
  • Apply Project Management Knowledge
  • Site Feasibility
  • Project Organisation Structure & Process
  • Develop Study Documents

Day Three

  • Clinical Research Materials
  • Biological Specimens
  • Data Collection & Data Management
  • Safety Monitoring

Day Four

  • Resource Management
  • Study Budget
  • Research Grants
  • IRB, Regulatory & HBRA
  • Research Agreements

Day Five

  • IM and SIV, Training of Study Personnel
  • Recruitment Plan
  • Study Monitoring
  • Project Management During Study
  • Be Audit/Inspection Ready
  • Study Closure

Application Procedure

To register for the CRC Level 2 Programme, please email your completed Registration Form to scriacademy@scri.edu.sg along with the required supporting documents when the registration opens.

Click here for the registration form.

Registration is on a first-come first-served basis and 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 Ministry of Health Holdings.

Course Fees

Full Price $3500.00 (inclusive of 7% GST)
CRCs from Singapore’s Public Healthcare Institutes under MOH Holdings (After 90% subsidy) $350.00 (inclusive of 7% GST)

Qualification

Participants who successfully complete this programme will receive a Certificate of Completion.

For downloading of the programme brochure, please click here .

Enquiries

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

« Back