Published Sep 12, 2008
VivaRN
520 Posts
Hello,
I started my 1st NP job a few weeks ago where part of my time is spent in clinical trials. I'm excited about it, but I will be the 1st NP ever with this group. Right now I'm hired as an RN and haven't yet taken boards - after I do my role will be re-evaluated.
There is a lot of discussion about how best to use the NP skills, as well as some guidelines from the nationwide clinical trials network about what an NP can do (for example, an NP can be a sub-PI but the PI is always an MD).
I want to be actively involved in the discussions about my role so that I can be as progressive as possible, and also pave the way for anyone after me.
Does anyone have any experience with this or ideas? I don't know any other NP's in research or who had to trail-blaze so to speak. If you work in research, what are your job responsibilities? If you were the 1st NP with a group, what was that process like?
It is also difficult because I will be a new NP... I don't want to get boxed in with a lot of regulation that I won't need once I'm more experienced. How do I navigate this to get the best outcome?
Thanks,
Corey Narry, MSN, RN, NP
8 Articles; 4,452 Posts
I have not had the daunting task of being the first nurse practitioner in my current and previous jobs in the NP role. Also, my involvement in clinical trials are limited -- mostly just being aware that a particular patient of mine is on a clinical trial of a medication or a device, definitely not in an investigator role. What field of health care are you starting in?
I was the third NP to join our team. By the time I started, the two pioneers were already in their role for at least two years. But I've heard stories of their struggles and growing pains. This is an ICU setting previously being staffed by surgical residents 24/7 and a rotating surgical physician assistant during the day time. Resident hours were being severely cut by the ACGME and the goal was to have consistency with a 24/7 provider presence. The surgical PA's were assisting with surgery and had little time left for 24/7 coverage. Thus, the NP's were tapped into the role.
The biggest problem the pioneer NP's had was resistance in the acceptance of their role from many directions. The residents did not know what the NP's can do. There were comments like "I can't give you the service beeper, my residency program director will kill me" or "you're not allowed to do that, aren't you?". The surgical PA's felt threatened and were under the impression that they were shoved out of ICU management so they were also giving the NP's much grief. It almost became a NP vs PA battle for a while. Fortunately, it was the ICU nurses themselves who welcomed the idea and was actually happy to see NP's in their unit.
The two NP's could not have survived if they did not know what they were doing. Truly, their biggest accomplishment was that they were able to prove that they are not incompetent. Both were new grads but had good critical thinking skills and assertiveness. They stood their ground when questioned. They opened their minds to learning new things and allied themselves with those who are willing to share knowledge and skills. Unfortunately, the task required the NP's to be present for long hours each day. They were literally working their butts off daily during the early months but fortunately were getting paid well for it. Credit is also due to the fact that the collaborating physician is very supportive and was willing to advocate for the two NP's all the way. Eventually, the trial by fire worked and more NP's were added including myself.
This may be a totally different experience than what you will be facing but I think a common theme in some aspects will emerge.
ghillbert, MSN, NP
3,796 Posts
I'm involved in a lot of clinical trials as a co-investigator. I'm NOT an NP yet. We do have NPs in the same role - and there's really no difference between the role of an NP/RN/any other co-investigator in a clinical trial.
All are required to complete necessary research ethics/IRB/protocol training, as well as any training required to fulfil the role (eg. I have to do neurocognitive testing, NIH stroke scale as part of the screening process).
The role of any co-investigator, including nurse coordinators, is to screen patients for enrolment, check inclusion/exclusion criteria, explain the trial to the patient, obtain informed consent, and then order/complete any required tests needed in the data collection schedule. We then maintain compliance with the clinical protocol, as we are periodically audited by either the IRB or the sponsor.
The two NP's could not have survived if they did not know what they were doing. Truly, their biggest accomplishment was that they were able to prove that they are not incompetent. Both were new grads but had good critical thinking skills and assertiveness. They stood their ground when questioned. They opened their minds to learning new things and allied themselves with those who are willing to share knowledge and skills. Unfortunately, the task required the NP's to be present for long hours each day. They were literally working their butts off daily during the early months but fortunately were getting paid well for it. Credit is also due to the fact that the collaborating physician is very supportive and was willing to advocate for the two NP's all the way. Eventually, the trial by fire worked and more NP's were added including myself. This may be a totally different experience than what you will be facing but I think a common theme in some aspects will emerge.
Thanks for the feedback. I'm glad it's not just me! I have experienced some of what you described, as far as staff being unclear and telling me "when you see that... be sure and get the doctor" when, although I will be a new grad, I know that is something I could at least initially handle on my own (like a rash).
It is also nice to know more about what to expect. As you described, I get that feeling I need to prove myself. Thankfully the RN's and MD's are wonderful - the field is HIV - and although I am younger I have a lot of respect for their experience. That has built a lot of good will between the RN's and myself.
I'm involved in a lot of clinical trials as a co-investigator. I'm NOT an NP yet. We do have NPs in the same role - and there's really no difference between the role of an NP/RN/any other co-investigator in a clinical trial. All are required to complete necessary research ethics/IRB/protocol training, as well as any training required to fulfil the role (eg. I have to do neurocognitive testing, NIH stroke scale as part of the screening process).The role of any co-investigator, including nurse coordinators, is to screen patients for enrolment, check inclusion/exclusion criteria, explain the trial to the patient, obtain informed consent, and then order/complete any required tests needed in the data collection schedule. We then maintain compliance with the clinical protocol, as we are periodically audited by either the IRB or the sponsor.
Interesting. I don't have a lot of experience in clinical trials, but with this group the RN's (nurse coordinators) do as you described, and the NP/PA can do things like physical exams, deciding if the rxn is related to the study drug, episodic prescription if the patient needs it etc. similar to MD's.
Why does your group employ NP's if they do the same job as the RN's? What do MD's do in your group?
It is nice to get other perspectives on NP's in research. Thank you!