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Course Description

"POWER UP YOUR CAREER" ONLINE SEMINAR SERIES—free with course registration

Prepare for diverse opportunities in the clinical research field


Clinical research: opportunities for improving quality of life
  • 100% online course, complete in 14 weeks
  • Enter the clinical research field, advance in your job or build useful new skills
  • Course aligns with Association of Clinical Research Professionals (ACRP) exam content
  • Payment plan, discounts available

The field of clinical research is focused on developing cost-effective ways to treat disease and increase quality of life through successful development and launch of new biologics, devices, and pharmaceuticals and by incorporating the science of genomics or personalized genetic prescribing.

Opportunities in the field are many and varied, ranging from the principal role of investigator to the supportive tasks surrounding regulatory compliance, scientific writing, marketing, data management and more. Employment settings include pharmaceutical, biotechnology, medical device companies, contract research, hospitals, educational institutions and independent contractors.

The Clinical Trials Management Online Certificate is offered 100% online and provides a broad overview of key competencies necessary for a successful understanding and conduct of the new product development process in today’s environment. Course topics include:

  • Clinical trials process, roles and responsibilities
  • U.S. regulatory compliance
  • Ethical and safety considerations
  • Data management and coding principles
  • Monitoring and oversight of clinical trials
  • New product introduction, branding and marketing

About the clinical research and product development field

New product development requires a broad collaboration among science and technology professionals who keep current in the medical and regulatory arena. The potential opportunities in the field of clinical trials management range from the principal role of investigator to the supportive tasks surrounding regulatory compliance, scientific writing, marketing, and retrieval of accurate and reliable data for submission to regulatory agencies.

The research team collaborates across several business units, starting with the sponsor of the investigative new product, to the clinical site that collects ongoing data from subjects receiving the product, to the sponsor or designee who monitors the quality of the data being collected. Professionals conducting clinical trials primarily come from health-care backgrounds.

Certification opportunity

The curriculum of the Clinical Trials Management Online Certificate covers core concepts consistent with the Association of Clinical Research Professionals (ACRP) certification exams, a valuable credentialing opportunity for clinical research professionals. For exam details, including eligibility requirements, visit Association of Clinical Research Professionals.

Clinical trials professionals are employed in a variety of settings:

  • Pharmaceutical companies
  • Biotechnology organizations
  • Medical device companies
  • Contract research organizations
  • Hospitals
  • Educational institutions
  • Independent contractors

A clinical research professional may serve as a clinical investigator, sub-investigator, clinical researcher, research nurse, administrator, coordinator, data manager, project manager, IRB coordinator, quality assurance specialist, regulatory affairs specialist, research pharmacist, consultant, or educator in clinical trials management.

Who should enroll?

  • Clinicians and other professionals currently involved in the clinical trials process
  • Professionals with a strong science or healthcare-related background wishing to expand their knowledge in the clinical trials field

Course Outline

To earn the Clinical Trials Management Certificate, all three of the following modules must be successfully completed with a grade of “C” or above.

Development: Setting Up the Environment for Success

This module provides an overview of the clinical and pre-clinical processes involved in setting up clinical trials, and the roles and responsibilities of those conducting and administering these processes. Topics include:

  • Ensuring that a proposed investigative site is qualified and appropriate for use in a clinical trial
  • Recruitment and retention of eligible study patients/participants
  • Compliance with U.S. regulatory bodies and ethical considerations: safety, efficacy, privacy
  • Comparison of human clinical testing models with animal testing models
  • Setting up for collection and delivery of unbiased, concise, and comprehensive scientific data
  • Code of conduct governing sponsors, sites, investigative personnel, and other affiliated parties
  • Case studies of ethical and safety violations in clinical trials, and their effect on new product development

Implementation: Carrying Through the Plan

This module focuses on the processes involved in conducting safe, thorough, and reliable clinical trials. Topics include:

  • Monitoring visits—purpose and importance of monitoring visits from the site and sponsor perspectives; roles and responsibilities of both site and sponsor in a successful outcome; essential points of a comprehensive site visit from both a regulatory and data management perspective; and what makes a highly proficient monitor
  • Obtaining valid and reliable data—components of an appropriate database, validation of associated systems, coding principles, and the sequence of events leading to a database lock
  • Emerging markets—how they contribute to the challenges of new product development, unique country/region mandates, effect of newly emerging markets in relation to the future of scientific experimentation
  • Reporting of safety concerns—how to appropriately report them to regulatory agencies, regulatory timelines for reporting, case studies

Integration: Creating the Package

This module focuses on the steps necessary for completion and evaluation of clinical trials processes. Topics include:

  • Ensuring that an investigative site has met all contractual and regulatory obligations
  • Follow-up checklist: disposition of outstanding product supplies, report data, etc.
  • Evaluation by the sponsor or agency regarding site and sponsor performance
  • Audits surrounding an NDA (New Drug Application) filing, random and for-cause
  • Introducing a product to health-care practitioners and consumers: market research, advertising principles, governmental rules and regulations, product branding
  • Effectively reporting the outcome of clinical trials, including unbiased reporting to potential consumers regarding the results, limitations, and availability of the new product

Notes

Prerequisites

It is expected that students entering the certificate will have a strong science and/or health-care related background. In addition, two years of college level coursework is recommended. The certificate provides the fundamental knowledge to enter the field of clinical research.

Technology requirements

     REQUIRED: laptop or desktop computer

  • Required: a PC or Mac, laptop or desktop computer must be used to complete course activities like tests, quizzes, homework, or chats
  • Required: high-speed Internet access
  • Required: Mozilla Firefox browser, version 10 or newer
  • Required: if not already installed on your computer, you may need to install these free plugins: Flash | Adobe Reader

     OPTIONAL: mobile device

  • Optional: most course video content can be viewed on a mobile device like a tablet, iPad or smart phone
  • Mobile devices cannot be used to complete required course components like homework, tests, quizzes, chats
  • Click here for details about mobile device compatibility

 

Testimonials

"I feel passionate about the clinical trial path, and I believe the knowledge I'm gaining will further my goal of pursuing opportunities to enter this field." - Daniel Hawk

"I came away with a complete overview of the drug development process." - Stephanie Givler

 

For More Information

 

 

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Enroll Now - Select a section to enroll in

Section Title
Clinical Trials Management Certificate
Type
Online
Dates
Feb 18, 2019 to May 20, 2019
Delivery Options
Online  
Course Fee(s)
Course Fee non-credit $2,125.00
Section Notes


Payment plan available

For details call 302-831-7600 or write to continuing-ed@udel.edu.


Wilmington University Elective Credit

The University of Delaware's Clinical Trials Management Online Certificate Program is an approved Lower Level Health Science elective (3 credits) for Wilmington University's Bachelor of Science degree in Health Sciences. For details, contact Wilmington University at coel@wilmu.edu.

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