Annex A. Levels 1 5 of the Clinical Research Coordinator Track in the Clinical Research WSQ Framework

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1 Annex A Levels 1 5 of the Clinical Research Coordinator Track in the Clinical Research WSQ Framework WSQ Higher Certificate in Clinical Research (Clinical Research Coordinators) Apply Drug Development Process in Clinical Research* Apply Research Methodology & Ethics Review Good Clinical Practice Guidelines (GCP) in Clinical Trials Establish & Exercise Good Clinical Practice (GCP) Guidelines in Clinical Trials Manage the Practical Aspects of Clinical Trials* Facilitate the Management of Clinical Trials Process and Interpret Laboratory Results in Clinical Trials Review and Manage Data Collection in Clinical Trials Apply Patient-oriented Skills in Clinical Research Review Current Trends in Clinical Research (Project) 8 Competency Standards, 10 Standard Assessment Plans and 1 Curriculum Training and Assessment Guide *Competency Standard has already been developed

2 WSQ Advanced Certificate in Clinical Research (Clinical Research Coordinators) WSQ Educate and Counsel Research Subjects WSQ Perform Randomization and Unbinding Procedure WSQ Manage Adverse Events and Safety Reporting WSQ Perform Investigation Product Management WSQ Perform Recruitment and Retention of Subjects in Clinical Trials* WSQ Follow the Clinical Trial Protocol which includes Assessing Subject's Conditions, Coordinating Physical Examinations per Protocol and Record Medical Drug History WSQ Manage Clinical Trial Essential Documents* WSQ Mentor Junior Clinical Research Staff WSQ Describe the Regulations and Obligations of Investigators for Medical Devices WSQ Maintain Data and Provide Study Reports WSQ Demonstrate Correct Technique in Parental Drug Administration WSQ Manage Lab Related Issues WSQ Document and Tabulate Financial Payments for the Clinical Study WSQ Ensure Proper Clinical Trial Submission and Approvals* WSQ Manage Workflow of Research Flow (Plan, Organise and coordinate) WSQ Communicate with Medical Workers WSQ Demonstrate Correct Technique in Administration of Intravenous Therapy WSQ Respond to Premature Termination or Suspension of a Clinical Trial 15 Competency Standards, 18 Standard Assessment Plans and 1 Curriculum Training and Assessment Guide *Competency Standard will be developed by another Training Provider

3 WSQ Diploma in Clinical Research (Clinical Research Coordinators) WSQ Perform Internal Quality Checks on Studies WSQ Assist in Creation of Clinical Research Project Budgets WSQ Handle Communication between PI and Sponsor Companies WSQ Ensure Proper Procedure for Safety Reports to Ecs and Regulatory Authorities WSQ Illustrate the Ethical Considerations in Vulnerable Subjects WSQ Prepare Monthly Roster to Maintain Study Drugs and Equipment WSQ Monitor Clinical Research Associates' Responsibilities WSQ Identify Drugs and Medication WSQ Managing Difficult Sites WSQ Demonstrate Good Conflict Management Skills WSQ Perform Drug Accountability WSQ Describe the Implications of Serious Misconduct 12 Competency Standards, 12 Standard Assessment Plans and 1 Curriculum Training and Assessment Guide

4 WSQ Specialist Diploma in Clinical Research (Clinical Research Coordinators) WSQ Assist PI in Protocol Development and Grant Application WSQ Perform Internal Checks on Studies Carried Out by Department WSQ Plan Research Logistics which include Liaising with Institutional Departments for Admin and Ancillary Support WSQ Select Site and Investigators WSQ Assist in Department Budget Preparation WSQ Design Case Report Form WSQ Assist in Database Design WSQ Manage Data Management Issues (eg. Query resolution, data cleaning, coding, database freeze/lock) WSQ Develop Clinical Research Protocol 9 Competency Standards, 9 Standard Assessment Plans and 1 Curriculum Training and Assessment Guide

5 WSQ Graduate Diploma in Clinical Research (Clinical Research Coordinators) WSQ Lead Team to Review and Formulate New and Revised Guidelines WSQ Manage Budgetary Controls WSQ Prepare Clinical Research Trial Budget WSQ Develop and Maintain Familiarity with Institutional Processes in Clinical Research WSQ Update Clinical Research Data: Prepare and Present Statistical and Progress Reports and Proposal WSQ Perform Financial Management of Grants and Contracts WSQ Establish Channels Internally and Externally with Professional Organisations around the World to Exchange Information Regarding Quality of Clinical Research WSQ Perform Cost Analysis of Resources and Services WSQ Assist in Development of Clinical Research Strategic Plan 9 Competency Standards, 9 Standard Assessment Plans and 1 Curriculum, Training and Assessment Guide