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Online Clinical Research Coordinator (CRC) Training: How to Conduct Clinical Trials

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How to Conduct Clinical Trials is a 100% online, self-guided training course for individuals seeking to obtain a position as a Clinical Research Coordinator (CRC) or, for physicians, a Clinical Investigator. How to Conduct Clinical Trials will teach you the day-to-day activities of a Clincial Research Coordinator; if you want to learn about conducting clinical trials at a hands-on, practical level, this is the course for you. The program takes approximately 18 hours to complete. Individual completion times will vary. There are no printed materials, the course is entirely online. A full course outline is presented below.

Click HERE to view an abbreviated demonstration version of How to Conduct Clinical Trials.


What is a Clinical Research Coordinator? A Clinical Research Coordinator (CRC), also known as a Study Coordinator, is responsible for organizing, managing and monitoring the conduct of a clinical research trial. Whereas the Clinical Investigator is ultimately responsible for the conduct of a clinical study, the Investigator will often designate many of his/her responsiblities to a Clinical Research Coordinator, including the following clinical study activities:

- Protocol development
- Recruiting, screening and enrolling human subjects
- Obtaining Informed consent
- Interacting with the sponsor drug/device company
- Reporting adverse events
- Scheduling patient visits, lab tests and procedures
- Collecting and recording clinical data
- Coordination of documentation for the IRB and sponsor
- Dispensing and tracking investigational supplies
- Maintaining hardcopy and computer files

devices


Career Opportunities

Clinical Research Coordinators may work out of hospitals, private research labs, or universities. The majority of these professionals possess a bachelor's degree in the sciences or nursing, and many go on to earn their master's degree. The ever-growing industry of clinical research has significantly increased the demand for Clinical Research Coordinators. According to the U.S. Bureau of Labor Statistics, the employment outlook for medical and health service managers, such as Clinical Research Coordinators, is good and employment growth in this field is projected at 23% from 2012-2022.

Salaries

Typical annual starting salary for a full-time Clinical Research Coordinator is $40,000. Senior coordinators and those in leadership roles can expect to earn upwards of $90,000. Salary is dependent upon location, employer, level of responsibilities, education, and experience.

 

COURSE OUTLINE

Module 1: Introduction

Module 2: The Drug Development Process

What is a Drug?

Drug Development

The Components of an IND

Clinical Development Plan

Phases of clinical Research

Regulatory Requirements & Guidelines

Declaration of Helsinki

Role of FDA

ICH Guidelines

HIPAA

Good Clinical Practice

Roles & Responsibilities

Sponsor's staff

Study Site Staff

Required Study Site infrastructure

Equipment

Study staff

Structure & role of IRB/IEC

Informed Consent process

Standard Operating Procedures


Module 3 Study initiation Activities

Study Site Staff's Evaluation of Study

Investigator Brochure

Protocol

Existing site facilities

Sponsor Evaluation of the Study Site

The Pre-study Visit

Study Site Documentation

Investigator's Essential Document File

Documents required for Study Initiation

Signed Protocol

Form FDA 1572

CVs

Financial Disclosure

IRB/IEC approval

Lab documentation

Study Document Review Simulation

Preparing the Study Budget

Managing Clinical Study Supplies

The Study Initiation Visit


Module 4: Ongoing Study Activities

Case Report Forms & Source Documents

Enrolling & Retaining Subjects

Performing Evaluations

Adverse Events

Sponsor Monitor Visits

Ongoing Reports

Drug Accountability (requirements & simulation)


Module 5 Study Close-Out Activities

Subject Completion/Termination

Sponsor Closeout Visit

Final Drug Accountability

Required Final Reports

Archiving the Master File

Sponsor & Regulatory Audits