CORE CLINICAL RESEARCH TRAINING (CCRT)

(Formerly: “Research Coordinator Course”)

 

Purpose


The purpose of the Core Clinical Research Training is to prepare participants to coordinate cost-effective health care research which protects the rights and safety of human subjects, achieves recruitment and retention outcomes and contributes to the science of health care. Participants completing the training will be prepared to coordinate research studies in compliance with the Good Clinical Practice Guidelines and federal regulations concerning human subject research.

 

About the Training

The training consists of 20 hours of lecture, seminar and workshop instruction planned over five sessions. Instruction is provided by qualified educators, researchers, Institutional Review Board for Human Research professionals, compliance auditors, VAMC compliance personnel, radiation safety officers, investigational pharmacists and experienced research coordinators. A competency examination is required at the conclusion of the training.

The training prepares the participant to successfully manage all phases of health care research from study initiation to close out. Participants meeting the ACRP criteria to take the clinical research coordinator certification examination will find this program a useful preparatory activity.

Target Audience

This training is open to all MUSC research coordinators, research regulatory affairs coordinators and study support personnel. Other interested MUSC and Ralph H. Johnson Medical Center, Department of Veterans Affairs, personnel are welcome, provided they first complete the online University of Miami CITI Training Course at http://www6.miami.edu/citireg/.

Objectives

Upon completion of the training, participants will have the information to be able to:

  1. Manage the day-to-day activities required of a study coordinator of human research protocols in order to ensure compliance with federal regulations, IRB policies and Good Clinical Practice Guidelines.
  2. Recruit, enroll and retain satisfied, informed research subjects.
  3. Organize efficient documentation systems and ensure reliable results on schedule within budget.
  4. Identify those agencies that regulate the conduct of human research and the resources available to answer questions.
  5. Ensure appropriate and timely required communication with sponsors, CROs, principal investigators, the IRB and subjects.
  6. Collaborate effectively with principal investigators, the IRB personnel and other health care professionals.
  7. Prepare for and participate in internal and external study audits.
  8. Identify the essential elements of an informed consent document that complies with the MUSC IRB Informed Consent Guidelines and the federal regulations governing the informed consent process.

To meet University requirements, all participants must

  1. Attend and complete the majority of the training sessions.
  2. Receive a satisfactory grade (74%) on the exam upon completion of the training.

OR

With documentation of at least 3 years of experience as a research coordinator at MUSC, successfully challenge the training by examination.

OR

Submit evidence of current certification by the Association of Clinical Research Professional and be exempt from taking the training or exam by challenge.