Clinical Research Coordinator Level 1 Programme

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Course Date
16 March – 8 June 2018
Every Friday, 9:00 am to 5:30 pm (except for 30 March)

Course Duration
Approximately 3 months / 12 weeks

Course Location
11 Slim Barracks Rise, NTU@One-North,
Singapore 138664

Registration Closing Date
7 February 2018

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 is designed for CRCs with less than one year of experience who are interested in gaining knowledge about coordinating clinical trials. The programme offers a comprehensive introduction to the operations of clinical trial at site and practical, hands-on training. The application of core CRC skills is reinforced through classroom discussions, case scenarios, demonstrations and practice-based activities. This programme is also valuable for individuals seeking a new career as CRC.

The SCRI Academy was launched in August 2017 by 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 wholly-owned subsidiary of the Ministry of Health Holdings.

This training programme is funded by Ministry of Health and in collaboration with Health Sciences Authority, Singapore Health Services, National Healthcare Group, National University Health System, 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 less than one year of experience
  • Aspiring CRCs or CRCs with limited commercial trial experience

Entry Requirements

  • At least a Diploma in Biomedical Sciences, Life Sciences, Nursing, Pharmacy or equivalent.

Course Outline

Week One

  • Overview of Programme
  • Introduction to Clinical Trial
  • Drug Development Process
  • ICH Good Clinical Practice
  • Clinical Trial Framework in Singapore
  • Research Team
  • Elements of a Protocol
Week Two

  • Overview of Key Research Therapeutic Areas – Diseases & Investigations
  • Common Medical Conditions and Related Medications
  • Understanding Eligibility Criteria in Clinical Trials and Related Investigations

Week Three

  • Overview of Singapore’s Healthcare System
  • Understanding Medical Records
  • Health Assessment by Observation
  • Administration of Medication
  • Specimen Collection
  • Basic Nursing Skills
  • Effective Communication

Week Four

  • Start-up Activities and Workflow
  • Investigator Meetings
  • Clinical Trial Agreement
  • Site Feasibility
  • Study Budget
  • Billing and Payment to Sponsor

Week Five

  • Ethics Board and Application Process
  • Deviations, Amendments and Reporting
  • Site Initiation Visits
  • Subject Eligibility and Randomisation
  • Blinding and Unblinding
  • Subject Visits, Follow-up and Retention
  • Subject Discontinuation
  • Payment to Subjects
  • Source Documentation

Week Six

  • Subject Recruitment and Documentation
  • Elements of Informed Consent Form
  • Informed Consent Process & Documentation
  • Vulnerable Populations and Safeguards
  • Waiver of Consent in Special Circumstances

Week Seven

  • Essential Documents
  • Investigator Site File
  • Tools and Templates
  • Monitoring Visit Preparation and Followup
  • Responding to CRF Queries

Week Eight

  • Clinical Trial Regulations
  • Clinical Trial Registry
  • Clinical Trial Safety
  • Reporting Adverse Events
  • Overview of GCP Inspection
  • Common Inspection Findings

Week Nine

  • Regulatory requirements for Clinical Research Materials
  • Management and Handling of Investigational Product, and Documentation
  • Drug Dispensing and Accountability

Week Ten

  • Use of Central Laboratory and Study Kits
  • Collection of Biological Specimens, Processing and Shipping
  • Management of Abnormal Findings
  • Study Equipment and Study Supplies

Week Eleven

  • Study Closure
  • Close-out Visit
  • Early Termination of Study
  • Record Retention
  • Questions and Answers

Week Twelve

  • MCQ Examination and Oral Assessment
  • Working Effectively with Investigator and Sponsor
  • Time Management and Relationship Management

Application Procedure

To register for the CRC Level 1 Programme, please email your completed Registration Form to scriacademy@scri.edu.sg along with the required supporting documents.

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 clusters under Ministry of Health Holdings.

Course Fees

Full Price $2,895 (inclusive of 7% GST)
CRCs from Singapore’s Public Healthcare Clusters under MOH Holdings (After 90% subsidy) $289.50 (inclusive of 7% GST)

Qualification

Participants who complete all modules of the programme and pass the examination will obtain:

  1. Certificate of Participation (Essentials in Clinical Practice) from Nanyang Polytechnic,
  2. E-Certificate of Achievement (Informed Consent & Subject Recruitment) from National Healthcare Group, and
  3. Certificate of Achievement (CRC Level 1 Programme) from SCRI Academy

For downloading of the programme brochure, please click here.

Enquiries

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

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