Advice From Study Coordinators!!!

  1. Hello, friends!! I am new to this site, and what a fin site it is! I am an RN with more than a few years of experience as a study coordinator. I took a long break from it and now I'm back in a new job (three weeks old) and IT HAS BEEN HORRIBLE!!! I am the 2nd coordinator on a BIG multi-center NIH funded study. Was SO excited to get this job. Turns out, however, that the PI is brand-new, and the other coordinator had NO CLUE. MAJOR protocol violations ALL OVER The place (including BIG-BIG-BIG consent issues, HIIPA violations, etc.). I discoverd and "outed" some of them last week (and solved them, since they were simple things to solve!!), but most of them were discovered just the past few days by the national data manager and are NOT at ALL simple to solve and now require MAJOR work to find, fix and document (of course, now to be done by ME) and are even BIGGER that the violations I found. I think the site will lose it's funding and get a big slap on the wrist. The 1st Study coordinator has been on vacation since I started on the job, so a lot has gone down, but I've already been threatened by her via voice mail and phone conversations. She's back on MONDAY.

    I have not yet enrolled a patient, nor signed one study document so I'm here in spirit, but not on paper, yet.

    Here is my dillemma: I am a NEW MOM. I took this job because they offered flexible hours. AND it seemed relative LOW stress, as it has been up and running for OVER A YEAR!!!

    With all this new info, my gut is telling me to RUN FOR THE HILLS before my name is actually on any ducment associated with the data!!

    Anyone with wise, sane advice for an exhausted, fretting, worried, belly-aching study-coordinator???!?!?!?!
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    Joined: Apr '06; Posts: 3