How to Staff Your Clinical Research Center

Good Clinical Practices dictate that a Principal Investigator maintains a list of qualified individuals to which any clinical research task is delegated. Realistically, the number of people a Principal Investigator needs depends on the amount of work available and the staff’s ability to multi-task. However, read on to determine the minimal staff needed to run an efficient clinical trial.

Difficulty: Moderate

Instructions

Things You'll Need:

• Basic Good Clinical Practices knowledge
• Clinical Research Center

1. 

   Hire a qualified Clinical Research Coordinator. There is a lot of interaction with the sponsor (and CRO, if applicable) and a smart Principal Investigator would have a good Clinical Research Coordinator to whom this task is delegated. This allows the Principal Investigator to concentrate on the patients, especially if he or she has a private practice or patients outside that of the clinical research. For information on hiring a qualified Clinical Research Coordinator, see http://www.ehow.com/how_2353380_choose-qualified-clinical-research-coordinator.html.

2. 

   Hire at least one Sub-Investigator. A Sub-Investigator is merely a backup for you and should be capable of performing your task in your absence. For example, if it is an investigational drug clinical trial, the Principal Investigator generally see patients and assess serious adverse events and abnormal laboratory values that may or may not be contributed to the investigational product. It is important that the sub-investigator also be able to assess abnormal laboratory values and serious adverse reactions.

3. 

   For more efficiency, hire a Research Assistant to help take some of the workload off of the Clinical Research Coordinator. The Research Assistant can transcribe the information recorded in the source notes unto the Case Report Form. The paperwork is time consuming and having a Research Assistant will free up the Clinical Research Coordinator for other clinical trials.

4. 

   Hire an Office or Business Manager. Negotiations and budget planning are two time-consuming tasks generally delegated to the Clinical Research Coordinator, in addition to all of the other duties. This is one of the biggest mistakes a principal investigator can make because most Clinical Research Coordinators are not trained in budgeting for clinical trials or in negotiations. Many Principal Investigators lose large sums of money because they accept the budget presented by the sponsor. Hire a qualified person to handle this task even if it is on a part-time or as needed basis.

5. 

   Hire a Quality Assurance manager. The QA person can help minimize the number of queries your research center receives from the sponsors by establishing effective operating procedures. This person conducts internal audits and ensures the training for the staff is current and procedures are written and followed.

Tips & Warnings

• At a minimum, hire the Clinical Research Coordinator and a Sub-Investigator. The others can be added as workload dictates.
• A Quality Assurance person will be invaluable if you should have a FDA inspection, so consider having a strong QA person available, even if it is on a part-time basis.
• Quality Assurance person should not perform any of the Clinical Research team duties as their main function is to provide compliance oversight.
• Even with adequate qualified staff, the Principal Investigator must still provide oversight. See what happens when Principal Investigators fail to provide adequate oversight for their clinical trials. See http://wqatsqatalk.blogspot.com/.

Resources

• WQATS, LLC
• How to Become a Clinical Research Assistant

[2besure]

on 6/24/2008 Is this what you do for a living? You have don two great articles on this.