[GirloftheSun]

Wanted to open a conversation about the growing trend of nonmedical personnel replacing research nurses. Personally, I think this is frightining, especially since people hired for these positions are often unqualified (BA's, no clinical research experience, no patient experience and NO license). These people are expected to run phase 1 and 2 investigational drug studies. There's no clear line that separates a nurse from a non nurse coordinator in these positions (unless the study requires procedures that can be done by a nurse or an MA). Not only that, what about the subjects, especially those who are very sick like cancer patients. The PI's mentality is, "I can get 2 coordinators for the price of a nurse; 2 for 1." Maybe I'm out of line and am not accepting of this evolving role. Have any of you seen this and what are your thoughts? We all worked hard to earn our nursing license and I think it's threatening, frighting, and discouraging to see people without an RN background do our jobs. I encourage you to share your thoughts. Thank you!

[anc33]

Honestly, I do not know who the role of research coordinator was intended for, nurse or otherwise. I do know many MAs, BSs, etc who are excellent research coordinators. I have heard from many research supervisors that they would much rather have a person that has a strong grasp of regulatory affairs, GCPs, FDA regs than one with an extensive medical background. I can say that in my 2+ years in Phase I studies that I have rarely drawn on any of my nursing skills. I find that in Phase I especially, the PIs are extremely involved leaving little, if any, decision making up to the coordinator. This may be very different in other organizations, I can only speak for my own. I am rather neutral on this subject. Regardless of who is best suited for the role, the ACRP certifies anyone who has worked in the coordinator capacity for over 2 years. The only requirement is that one has a HS diploma. They have only recently begun asking for college transcripts, etc, but have not yet upped the educational requirement for certification.

[GirloftheSun]

I think it varies from institution to institution. We have coordinators with no experience you've described above who are in charge of phase 1/2 trials, with little PI involvement. To add, these are very sick patients, all taking 30+ meds. I don't use my "RN" skills as much in this position but I feel I use my BSN all the time. Well, actually, my RN skills come in hand as to recognizing medications, side effects, complication etc. I would not feel comfortable putting my license on the line if I ws a PI, but....each to their own.

[pattymac]

I know where you are coming from. A lot of it seems to be that RN's wanting to do research are very scarce. Most of our coordinators have Master's or a least a Bachelor's degree. I do have some issues with what they do/don't do, but since I can't change it, I do my job and let the supervisors worry about everyone else. I do try and teach what I can when I see something that needs to be done differently, but for the most part, everyone does what they seem to be capable of doing. I don't think it's going to change any time soon.

[GirloftheSun]

I don't think it's going to change any time soon.[/quote]

I think you have a good attitude about this, and I also think you're right about it not changing soon. I remember when I started research nursing I had to start with the blood draw studies and such since I didn't have experience in clinical trials. Now, our group hires people without college degrees or license experience in clinical trials etc to jump right in. I wish I could have a better attitude to support this but right now I cannot. I've worked way to hard to beome a research nurse and now anyone can be hire to do it.

[anc33]

When I first started in research I bought some books on the subject, one that was written by an MD. They advocated that the best person for a coordinator job is one who is highly organized. They even said that one's secretary may be the ideal candidate. So I think what we are up against is the desire to keep costs down. Basically we have the same issues that nurses who work in medical offices have. Their competition is uncertified, often uneducated medical assistant who require helf the salary.

[outcomesfirst]

I think it is really dependent on the sponsor, complexity and type of trial. Currently I am working on a critical care trial. The sponsor is only approving sites with RN coordinators and is only using RN monitors. From what I have seen, there are three types of physicians involved in trial research: 1. only involved to make money = SC does all work and never works with the budget; 2. really interested in the research, only participates in research in their area of interest, collaborates with the SC, leaves trial details (budget) to SC or admin; 3. a bit of both, high professional standards, only works with staff who are competent and qualified. I like working with #3, they are pragmatic idealists, are personable and seem to provide the best data.