Newbie with clinical trial coordinator...

Rob72, ASN, RN · Aug 29, 2011

Generally, it takes about 2 years to "get your feet set", assuming you do more than vitals and drug administration.

Ideally, you should not have more than 3-6 studies (depending on complexity) at any given time. Again, this depends on the model of Nurse/Coordinator your employer uses. We do everything from contract and budget (routing & negotiation) through the direct care. Some places only have the RNs draw blood, dispense med 7 do the education, so it does vary.

As with any specialty, there are horror stories. I've heard one PI state that it was necessary to, "Overwhelm the new hire for the first 6 months to one year. If they start off lazy, you'll break that...!":rolleyes: Of course, this is said by someone who's never had a week-long visit from the FDA.

Most newer (under 50 yo) University PIs are beyond that olde-school crap, and are good employers. A research facility (locally, Sooner Clinical Research is a good example) are very professional and competent, because they run a variety of studies, for a variety of specialties, and have frequent audits.

Above all, follow the letter of the law. "Fudging" will get you barred from research, and/or fined. The PI is primarily responsible, but gross negligence (greed) has sent more than a few folks down the tubes.

anc33 · Aug 29, 2011

I am going to say it takes one year to start to feel comfortable is three years to really feel competent. However, you will never know it all because oncology and research are two fields where there is a lot of ongoing change. You can make this field a paycheck or a career, but it is really easy to spot the ones that are phoning it in.

Just know... your first priority is always keeping your patients safe. Your second should be maintaining the integrity of the research and third is keeping your PIs out of trouble. Some PIs are more difficult to tame than others. Don't trust any of them to know the protocols. Most are aware of the title and maybe some key inclusion/exclusion criteria. They will need you to hold their hand. And don't be afraid to speak up if and tell them they are wrong or need to do X instead of Y, etc. And you are going to make mistakes. It is OK, that is how you learn. People who A) do not like critique and B) those who do not learn from past experience do not do well in research. You will be critiqued, it is a sport for some monitors.

If you are a member of NSABP they actually have a mentor program that may be useful. I would also join either ACRP (more expensive but more active) or SoCRA (more oncology CRCs). ONS has a clinical trials SIG and some educational materials on their site. Spend some time reading the CFR and FDA guidances. If you do not have much background in stats or epi do a little research so you can better understand the scientific design of the protocols you are coordination. Never be afraid to ask questions. Best of luck.

OncologyRN23, BSN, RN · Aug 30, 2011

Thank you both for your honest responses!!

I am a little be nervous about this new job, because this is certainly branching out for me! Please keep me in your prayers!

Thanks!