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Clinical Research Nurse (CRN) {CACRS 18 Credits} Member Price: C$595 Non-Member Price: C$845

Clinical Research Nurse (CRN) {CACRS 18 Credits} Member Price: C$595 Non-Member Price: C$845

Register before May 15, 2019 and save $150.00 when you enter Promo code: CRN150

Starting Date: June 01, 2019

Member Price: C$595
Non-Member Price: C$845

*Prices are in Canadian Funds

Course Overview

The Clinical Research Nurse (CRN) has a vital role in the conduct of a clinical trial and is a key liaison between the Principle investigator, subject, IRB, Clinical Pharmacist and sponsor. This Clinical Research Certificate program will prepare you to assume the duties of managing and organizing a clinical trial. Program will provide a comprehensive introduction to clinical research and the job functions of the Clinical Research Nurse for pharmaceutical drug and biologic trials.Standards and regulations that affect conducting clinical trials and a basic understanding of ethical principles and data organization are covered.This program will provide core skills and encourage critical thinking to those individuals looking to support, facilitate, and coordinate the daily activities of clinical trials.Good Clinical Practice (GCP) skills are reinforced through activities such as non-graded multiple choice questions and scenario review. Non-graded knowledge assessment will follow each module. Communication and effective time management skills as being essential to clinical research professionals are also covered. Upon course completion, participants will be provided with training certificates.

Learning Objectives:

  • Upon completion of this course, participants should be able to:
  • Understand the roles and responsibilities of the Clinical Research Nurse
  • Prepare for what a pharmaceutical sponsor is looking for in a research site during a pre-study evaluation or site selection visit
  • Understand the requirements for source documentation, case report forms, study tool development, and standard operating procedures (SOPs)
  • Define clinical trials cost drivers
  • Maintain ethical, legal, regulatory, and professional standards associated with clinical research
  • Define informed consent requirements and learn the process of conducting informed consent
  • Understand the techniques of subject selection, recruitment and retention
  • Discuss Participants safety and Adverse Events
  • Discuss regulatory compliance and quality assurance as it relates to audits and inspections

Course Outline:

  • Module 1: Introduction to Clinical Research, Investigational Product Development: Pharmaceutical Drug, Regulatory Oversight
  • Module 2: Good Clinical Practice (GCP): What are They and Why Do We Have Them
  • Module 3: The Clinical Research Team: Roles and Responsibilities
  • Module 4: The Principal Investigator and Site Selection
  • Module 5: Subject Selection, Recruitment and Retention
  • Module 6: ICH GCP E6 (R2): Major Changes and What Do They Mean For Subject Recruitment and Retention
  • Module 7: Clinical Study Protocol Breakdown and Feasibility Evaluation
  • Module 8: Source Documentation, Case-Report Forms, Study Tool Development, and Standard Operating Procedures
  • Module 9: Informed Consent Requirements and Process
  • Module 10: Study Initiation, Start-up, and Ongoing Management Activities and Sponsor Expectations
  • Module 11: Participant Safety and Adverse Events
  • Module 12: Regulatory Compliance and Quality Assurance: Audits and Inspection
  • Module 13: Effective Time Management Skills
  • Module 14: Communication Skills

At a Glance:

Target Audience:

  • Nurses (Registered Nurse and Nurse Practitioner) Interested to Pursue a Career inClinical Research
  • New Nursing School Graduates
  • Nurses Already Working in Clinical Research as CRCs with Less Than Six Months of Experience.
  • Certified Clinical Research Nurses Who Would like to Maintain Their Certification by Earning Credits.
  • Learning Level: Basic
  • Total Length of Course: 18 Hours
  • CACRS Credits: 18
  • Delivery Formats: Online
  • Certificate Program:¬† A Certificate of completion will be sent by mail in two weeks after passing the final online MCQs exam. Certificate contains the logo and the seal of the association.
Enrollment Period: Access to the program is valid for 6 months 

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