Clinical Research Training Specialists 140 Hour CRA Certificate Program Medical Research Management
Home   Home
Help   Help
Sitemap   Sitemap
Contact   Contact Us
Login   Login
140 Hour CRA Certificate Program
Fundamentals Home
Who is MRM
What is a CRA
About the Course
Course Locations
Who is Eligible
Registration & Fees
Tuition Reduction
Accreditation
Resume Wizard
Testimonials
FAQ
Contact Us
Download Brochure
Career Center
Alumni
CRA Employers
 
Home About Us Fundamentals Seminars E-Learnings Contact Us  

Who is Medical Research Management Inc. (MRM)?
A Clinical Research Associate, also known as a Monitor, is an individual that oversees the progress and conduct of a clinical trial. A clinical trial is usually implemented by physicians at a hospital, clinic, or physician's office. The CRA is required to oversee the initiation, progress, and conduct of the clinical trial to ensure the scientific integrity of the data collected, and the protection of the rights, safety, and well-being of human study subjects.

The CRA’s responsibilities include but are not limited to the following:

  • Monitoring that the physician adheres to Good Clinical Practices and the study protocol.
  • Performing study drug accountability;
  • Verifying the documentation of the informed consent process for each study subject;
  • Ensuring that non-serious and serious adverse experiences are properly documented and reported.
  • Reviewing the case report form against the subject's medical record for completeness and accuracy;
  • Ensuring the filing and maintenance of the required regulatory documents.

The CRA frequently has a health care or science background (e.g. nurse, medical technologist, or physical therapist; or Bachelor's, Masters, or a Ph.D. in a science). The CRA is usually employed by a pharmaceutical company, contract research organization, academic institution, or site management organization. A CRA can work either in-house or in the field, requiring 50-70% travel. A field monitor will visit multiple sites and interacts with the study coordinator and the investigator conducting the trial.

Pharmaceutical companies are presently seeking to reduce the development time necessary for their products to receive FDA approval for marketing. Monitoring of a clinical trial is the first mechanism in identifying potential data discrepancies and regulatory issues. Inadequate monitoring can jeopardize the safety of the study participant and/or is a leading contributor to the delay in gaining drug approval. A well-trained and knowledgeable CRA plays a vital role in protecting the study participant and helping to reduce the time between drug development and marketing approval. The demand for knowledgeable and trained CRAs continues to grow, however the supply is limited.

ENTER ALUMNI
 
ENTER eMPLOYERS
 
ENTER COURSE
 
 
   
Fundamentals Home | Who is MRM | What is a CRA | About the Course | Course Locations | Who is Eligible | Registration & Fees | Tuition Reduction | Accreditation
Testimonials | FAQ | Contact Us | Download Brochure | Career Center | Alumni | CRA Employers
COPYRIGHT © 1999 - 2007. MEDICAL RESEARCH MANAGEMENT. All Rights Reserved.