The Clinical Research Site is the focal point of all clinical trials. This is where the subjects are recruited and followed closely allowing for collection of data as required by the protocol. One must never forget the importance of a well organized and professional research site when it comes to the successful conduct of a study.
The key ingredients to a successful clinical research site are: committed and interested physician(s) willing to serve as investigators, a dedicated person to serve as the clinical research coordinator (CRC) and other ancillary staff as required by the types of studies and workload of the site. The days are long gone when it is acceptable for the physician to use the regular clinic nurse as a coordinator. Due to the many requirements of compliance with the details of protocols and Federal Regulations, sponsors are requiring sites have dedicated staff serve as the CRC.
Once you have decided to become a clinical research site and are willing to make the commitment, it's time to get the appropriate staff in place. The first position to be filled is that of a Clinical Research Coordinator (CRC). Your role as an investigator will be much easier if you are able to hire a CRC who has been certified through the Association of Clinical Research Professionals (ACRP). If the CRC has this certification (CCRC), you can be assured that she/he has at least two years experience in coordinating clinical trials and has knowledge of the Federal Regulations and ICH Guidelines. This certification program has been in place since 1992, so your chances are good of finding a CCRC simply by advertising in the local newspapers.
Initially this is the only staff person necessary. As your clinical trial program grows, it is important to add an assistant to the staff primarily for the purposes of phlebotomy. This is a very time consuming job and critical to the success of a clinical trial program. If the coordinator does not have to do the phlebotomy, they can generally coordinate 3-4 trials at once. It's best if they are recruiting for only one study at a time since that is where the major effort is required.