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Online Clinical Research Training for CRAs: Monitoring Clinical Studies

If you're thinking about a career in clinical research or the pharmaceutical industry or you're a new Clinical Research Associate (CRA) looking for a practical clinical trials course covering the day-to-day activities of a CRA, Monitoring Clinical Studies is a great course for you. And we provide job assistance for students who successfully complete the course!

Click HERE to view a demonstration version of Monitoring Clinical Studies.

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Monitoring Clinical Studies is a 100%-Online, self-guided, clinical trials training course for individuals seeking a position in the pharmaceutical industry as a Clinical Research Associate (CRA) or related position; or for current Clinical Research Associates who need to learn the day-to-day roles and responsiblities of a CRA and/or prepare for CRA certification. Your tuition includes 90-days' access to this 50-hour* program (you have 90-days to complete the program), which you can access 24/7 anytime/anywhere, as well as job assistance for those students looking for a new position in clinical research.. See the detailed course outline below. Questions? We're happy to answer them. Feel free to give us a call at 1-800-683-6013.


Why this 50 + hour* training program is best for you:

START TODAY! You can start right away. No need to wait around for a course that fits in with your schedule.

GET "HANDS-ON" LEVEL EXPERIENCE: You will participate in many simulations during the training program that will give you "hands-on" experience in actual monitoring situations such as Investigator selection, IRB approval, CRF review, source document verification, drug accountability and adverse event assessment. See the detailed course outline, below.

JOB SEARCH ASSISTANCE INCLUDED: We provide job search assistance for those seeking a new position.

USE YOUR SCIENCE DEGREE: If you have a biology degree or other science-based education and are having trouble finding a job, CRA training can help you get a job in the pharmaceutical industry!

GET CERTIFIED: This course will help you to prepare for the CRA certification exam.

LEARN MORE: Proceed through the course as fast or as slow as is comfortable for you. Focus on what you don't know; skip what you already know. Review the materials as often as you need to reinforce your learning.

WORKS ON ALL MOBILE DEVICES! LEARN ANYWHERE, ANYTIME.

SAVE MONEY: 50 hours of training for less than $1,000. And since it is all online, you save the cost of airfare, hotel, and associated costs of a non-local, live course.

 

COURSE OUTLINE: MONITORING CLINICAL STUDIES

THE DRUG DEVELOPMENT PROCESS

What is a Drug?

- Where Does a Drug Originate?

Steps in Drug Development

- Pre-Clinical

- Clinical Development

The Business Side of Drug Development

Regulating Drug Development

The FDA

Food and Drug Laws

Review Boards and Advisory Committees

The International Conference on Harmonisation of Technical Requirements of Registration of Pharmaceuticals for Human Use (ICH)

GCP - Good Clinical Practice, HIPAA

Standard Operating Procedures

New Drug Application (NDA)

Your Role in the Drug Development Process

Test on Section One

INITITATING THE STUDY

Selecting Investigators: Is It Really That Important?

Where To Start?

And when?

Your Role

The Investigator's Role

Study Specific Needs

What Specifically Do I Look For In An Investigator?

Medical training

Medical specialty

Ability and experience

Reputation, level or prominence

Required subject population; access to subjects

Geographic concerns, site accessibility

Facilities and equipment

Staff

Concurrent studies

Availability (study start date and duration)

Cost factors, budget

Personal traits

Where Can You Find Investigators?

In-House Network

Professional Network

Literature Review

Directories

Additional Sources

Caution! "Blacklists"

Contacting Potential Investigators

Step 1: Initial Contact

Step 2: Initial Contact Follow-up

Step 3: Checking Out the Site

Evaluation

Prioritize Your List of Candidates

Make the Decision

The Pre-Study Visit

Why Have a Formal Meeting?

When to Visit

To Visit or Not to Visit?

Planning the Visit

First Things First

Estimate How Much Time You Need

Set an Agenda

Contact the Site

Confirm Everything!

At the Site

Evaluate the Facilities

Meet with the Investigator

Meet with the Staff

Simulation: Informed Consent Form review and critique

Pre-Study Visit Report and Follow-up

Site Selection

Next Steps

Simulation: IRB Approval Letter Review and critique

The Study Initiation Visit

Why Have a Formal Visit?

Before the Visit

When to Visit

Planning Your Visit

Estimate How Much Time You Need

Set an Agenda

Contact the Site

Confirm Everything!

Gather Meeting Materials

Private Meeting with the Investigator

The Group Meeting

Protocol Review

Study Drug Administration

Assessment

Laboratory Procedures

Adverse Events

Recruitment

Inclusion/Exclusion Criteria

Informed Consent Instructions

Enrollment

Withdrawals

Handling Objections to the Protocol

Case Report Form Review

Reviewing the Form

Corrections

Common Errors

Managing clinical supplies

Receiving

Storing

Dispensing

Ordering

Return

Other Study Obligations

Monitoring Visits and Audits

Investigator's Essential Document File

Record Retention

Contact

Final Meeting with the Investigator

Documentation and follow up

 

MONITORING THE STUDY

Types of Monitoring Visits

Frequency of Monitoring Visits

Preparing for the Monitoring Visit

Conducting the Monitoring visit

Initial Monitoring Visit Tasks

Monitoring Study Progress

Medication Inventory and Accountability

Simulation: Performing Drug Accountability

Reviewing CRFs

Simulation: Case Report Form Review & Protocol Compliance

Simulation: Source Document Verification

Adverse Event Classification & Reporting

Collecting Paper CRFs

A Final Word - Be Efficient

Between Monitoring Visits

After The Monitoring Visit

Monitoring Visit Report

Documenting Telephone Conversations

Follow Up

 

CLOSING THE STUDY

Study Closeout Visit

When to Visit

Prepare for the Visit In-House

Contact the Investigator

At the Site

Reconcile Clinical Supplies

Finalize all Data Issues

Investigator's Essential Document File

Prepare the Site for an Audit

Final Meeting with the Investigator

Documentation and Follow Up

Closing Out a Single Site

 

MASTERY EXAM